Total knee arthroplasty (TKA) is one of the most successful interventions to manage pain and dysfunction of the knee joint for end-stage osteoarthritis.1–3 As the prevalence of osteoarthritis has increased, so have the number of TKAs,4 making them one the most common inpatient surgical procedures covered by Medicare.5 Physical rehabilitation is typically offered to patients who have undergone a TKA with the goal of optimizing postoperative outcomes, including strength, physical function, pain reduction, and return to normal activities of daily living. However, rehabilitation is not a single intervention but rather a complex intervention that incorporates multiple specific components (i.e., strength exercises, stretching) that may be initiated at different times after surgery, performed at different frequencies and intensities, delivered by different personnel, delivered in different settings, and may be personalized to individual social and financial circumstances and responses to surgery and rehabilitation.6 Thus, while rehabilitation after TKA in generally known to be effective (i.e., compared with no rehabilitation) it is unclear which specific rehabilitation interventions or components within interventions are most effective and should be replicated in practice to achieve the best clinical outcomes and reduce avoidable complications or joint failures.7 Understanding the comparative effectiveness of diverse rehabilitation programs and their component parts is of particular interest to health systems in the context of bundled payment models; as major TKAs and bundled payment models become more prevalent,8 health systems and payers would like to understand what are the most effective and cost-effective care for patients receiving TKA without compromising patient outcomes.9–11
We conducted a systematic review (SR)12 under the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center Program to understand the effectiveness and comparative effectiveness of prehabilitation and rehabilitation for TKA and total hip arthroplasty (THA; see questions for the full review in Appendix A, Supplemental Digital Content 1, https://links.lww.com/PHM/B644). In this article, we address the effects and harms of rehabilitation for patients who underwent TKA on patient-reported outcomes, performance-based outcomes, and healthcare utilization after surgery. In companion articles, we address rehabilitation after THA13 and prehabilitation before TKA and THA.14
The Brown Evidence-based Practice Center used established SR methodologies as outlined in AHRQ Methods Guide.15 The SR was registered in PROSPERO (registration number CRD42020199102) and is reported in accordance with the Preferred Items for Reporting in Systematic Reviews and Meta-Analyses16 (Appendix B, Supplemental Digital Content 2, https://links.lww.com/PHM/B645). We developed the protocol with input from a broad panel of stakeholders (https://effectivehealthcare.ahrq.gov/products/major-joint-replacement/protocol). Detailed descriptions of the SR and methods can be found in the full AHRQ report12 and Appendix C (Supplemental Digital Content 1, https://links.lww.com/PHM/B644).
Data Sources and Searches
For the full SR, we conducted literature searches in MEDLINE (via PubMed), PsycINFO, Embase, The Cochrane Register of Clinical Trials, CINAHL, and Scopus, restricted to 2005 through May 3, 2021. Studies published before 2005 were excluded to account for changes in TKA management, particularly postoperative protocols (e.g., enhanced recovery after surgery protocol and rapid hospital discharge) more commonly used since the 2000s.17 See Appendix C (Supplemental Digital Content 1, https://links.lww.com/PHM/B644) for search strategies.
All identified citations were independently double screened using Abstrackr (http://abstrackr.cebm.brown.edu) by a team of six researchers. Conflicts were resolved by group discussion. All potentially relevant studies were rescreened in full text in duplicate.
To answer our questions about rehabilitation for TKA, we included studies of adults who had undergone elective nonrevision, unilateral TKA for primary osteoarthritis and who received a rehabilitation program less than or equal to 6 mos after surgery. We excluded studies of patients with nonelective (e.g., emergency), bilateral, or revision TKAs, or TKA for conditions other than osteoarthritis. We defined rehabilitation as active, structured physical activity, or activities designed to attain measurable goals of reducing impairments and improving movement-related function as defined by the International Classification of Function, Disability, and Health.18 The rehabilitation intervention had to be delivered, supervised, and/or monitored by a healthcare professional or other trained individual (e.g., physical therapist, rehabilitation nurse, health educator with training in exercise delivery or rehabilitation). Rehabilitation could be combined with adjunctive modalities, although we excluded studies designed to evaluate adjunctive modalities on their own.
Rehabilitation could be compared with other rehabilitation (of different content), rehabilitation with an adjunctive modality or rehabilitation of similar content that varied in terms of intensity or method of delivery (e.g., by different personnel or in a different setting). We did not evaluate pharmaceutical or over-the-counter interventions as cointerventions.
We included performance-based measures, patient-reported outcomes, healthcare utilization, and harms (specifically from rehabilitation). We included randomized controlled trials (RCTs) and nonrandomized comparative studies (NRCSs) that used analytic methods to minimize selection bias (e.g., multivariable adjustment, propensity score analysis). Finally, we required at least 20 participants per intervention group.
Data Extraction and Quality Assessment
From each study, we extracted data on study design, population characteristics, outcomes, and results into the Systematic Review Data Repository (https://srdrplus.ahrq.gov/public_data?id=2965&type=project). Two independent reviewers (one with expertise in rehabilitation content, and the other with expertise in complex intervention taxonomies) separately extracted intervention details. We first categorized the content of the rehabilitation interventions according to a categorization scheme adapted from ongoing work by Oatis et al.19 and Franklin.20 The taxonomy comprehensively lists 147 specific rehabilitation content components that are hierarchically linked to larger rehabilitation goals. The larger component goals include strengthening exercise, aerobic exercise, flexibility exercise, balance-motor/learning-agility exercise, task-specific training, patient education, and adjunctive modalities. We extracted information on the goals of the exercise(s) and the specific exercises used to achieve these goals; information on whether the rehabilitation was progressive (i.e., changed over time) and, if so, whether it was appropriate (i.e., according to patient-specific parameters assessed by the therapist); and who delivered the intervention, (personnel), how (mode of delivery), and where (setting). We did not assess dose, intensity, and duration aside from minimal criteria needed to meet our rehabilitation definition or in cases where rehabilitation content was the same but varied only in terms of dose, intensity, or duration. More details about how we operationalized the taxonomy and our extractions of the rehabilitation interventions can be found in Appendix C (Supplemental Digital Content 1, https://links.lww.com/PHM/B644).
To assess study methodological quality, we used the Cochrane risk of bias tool for RCTs21 and for NRCSs, elements from the ROBINS-I tool22 related to confounding and selection bias. For RCTs, we also used items from the National Heart, Lung, and Blood Institute tool on the adequacy of descriptions of study eligibility criteria, interventions, and outcomes.23 Each study was extracted and assessed for methodological quality by one methodologist and reviewed and confirmed by at least one other experienced methodologist. Disagreements were resolved by discussion among the team.
Data Synthesis and Analysis
We compared interventions with their comparators for their effects, using mean differences (MDs) between groups for continuous outcome data. For categorical outcomes, we evaluated odds ratio.
The heterogeneity of the interventions and their comparators precluded identification of meaningful groupings of similar interventions and comparisons for synthesis. In the absence of this, we grouped studies into the time points in which they were delivered (acute vs. postacute) and, where possible, the type of comparison evaluated (e.g., more intensive rehabilitation vs. less intensive rehabilitation; similar rehabilitation offered at different time points or intensities, etc.) We report outcomes under the four following outcome categories: body structure and function; activity and participation; other patient-reported; and healthcare utilization. Given intervention heterogeneity, we determined that meta-analysis was not warranted (i.e., average result would not have been interpretable/meaningful) and instead summarize results narratively.
For all analyses, we graded the strength of evidence (SoE) as per the AHRQ Methods Guide.24,25 For each SoE assessment, we considered the number of studies, their designs, limitations/risk of bias, the directness of the comparisons to the research question, consistency of study results, precision of estimates of effect, likelihood of reporting bias, and other limitations. Based on these assessments, we assigned a SoE rating as being either high, moderate, or low, or there being insufficient evidence to allow a conclusion.
Role of the Funding Source, Stakeholders, and Reviewers
The AHRQ Learning Health System (LHS) panel nominated this topic for SR to the AHRQ. A member of the LHS panel joined stakeholder panels who contributed to discussions that helped refine the key questions and protocol. The AHRQ program officer, the LHS member, and other reviewers (both invited and public) provided comments on draft versions of the protocol and full evidence report. The LHS partner and AHRQ did not participate in the literature search, determination of study eligibility criteria, data analysis, study evaluation, or interpretation of findings.
The literature searches yielded 22,361 citations (for all topics addressed in the full report). We found 1016 citations to retrieve for full-text screening (Appendix D, Supplemental Digital Content 1, https://links.lww.com/PHM/B644) of which 53 studies (49 RCTs and 4 NRCSs) reported in 61 articles evaluated the effectiveness of rehabilitation among patients who had undergone TKA.26–86
Details on study designs, population characteristics, and detailed coding of rehabilitation interventions evaluated for TKA patients can be found in Appendices E and F (Supplemental Digital Content 1, https://links.lww.com/PHM/B644), respectively. The 53 studies assessed a total of 11,533 patients. The studies enrolled between 41 and 2426 participants each. The average ages of participants varied across studies, ranging from 54 and 79 yrs. The percentage of women in the studies also varied across studies, from 27% to 100%. Six studies reported data on previous contralateral TKA, which ranged from 13% to 43%. Most studies were conducted in Europe (n = 25), followed by Asia (n = 13), North America (n = 9), and Australia (n = 6). Three studies were funded in part by industry that produces medical equipment or telecommunication technology.67,72,83 Thirty of the 49 RCTs were rated as moderate risk of bias due to lack of blinding. The remaining 19 RCTs were rated as high risk of bias due to additional threats to the randomization process (Appendix G, Supplemental Digital Content 1, https://links.lww.com/PHM/B644). All four NRCSs were rated as moderate risk of bias based on their nonrandomized design (the studies were not rated as high risk of bias because they adjusted for important confounders using appropriate methods as per our inclusion criteria; Appendix H, Supplemental Digital Content 1, https://links.lww.com/PHM/B644).
All studies were unique in terms of rehabilitation goals and specific exercise components used to address these goals; no rehabilitation intervention was evaluated by more than one study. Across studies, rehabilitation interventions were delivered in varying settings, by diverse personnel, at varying intensity, and at various points during the rehabilitation period.
Description of the Acute-Phase Rehabilitation for TKA Evidence
Twenty-one studies (18 RCTs and 3 NRCSs) evaluated acute-phase rehabilitation in 6049 patients (summarized in Fig. 1). Of these, four RCTs evaluated novel (hypothesized better) rehabilitation programs versus standard care or alternative rehabilitation programs,37,40,53,73 four RCTs evaluated comparatively similar rehabilitation programs delivered with varying intensity and/or timing,46,49,54,85 six studies (3 RCTs, 3 NRCSs) evaluated comparatively similar rehabilitation programs delivered in different settings or by different personnel,32,35,47,63,64,67 and seven RCTs evaluated comparatively similar rehabilitation programs with or without an adjunctive modality.28,42,72,78,80,84,86
Acute-phase rehabilitation interventions were initiated in-hospital from immediately postop to 2 wks after surgery. All studies evaluated unique rehabilitation interventions comprised varying goals and exercise components (as coded by the taxonomy) in different combinations, delivered in varying settings (by different modalities) by diverse personnel (Figs. 1–3, Appendix F, Supplemental Digital Content 1, https://links.lww.com/PHM/B644).
Of the 18 acute-phase studies that provided some description of their rehabilitation content, active rehabilitation was reported in all 36 arms (i.e., intervention and control arms). All arms included exercises to address the goal component of flexibility (n = 36/36). Most studies also included exercises address the goal of strength (n = 32/36), task-specific training (n = 32/36), patient education (n = 15/30), and balance-motor-learning-agility (n = 12/36). Aerobic exercise was not commonly targeted in acute-phase rehabilitation interventions (n = 6/36).
Specific exercise components within rehabilitation goal components varied across programs (Figs. 2 and 3).
Nine studies included an adjunctive modality in combination with the rehabilitation program: two47,49 with the same adjunctive modalities delivered to both study arms and seven28,42,72,78,80,84,86 where the added benefit of adjunctive therapy was the question of interest and thus the adjuvant modality varied between arms. The adjunctive modalities evaluated in these seven studies included neuromuscular electrical stimulation (NMES, n = 3 RCTs); transcutaneous electrical nerve stimulation (TENS, n = 1 RCT), biofeedback (n = 1 RCT), motor imagery (n = 1 RCT), and continuous passive motion (vs. active-heel slides, which was the comparison of interest for this review; n = 1 RCT).
Eight studies reported some form of exercise progression, of which three were assessed by clinical experts on our team as appropriate (i.e., progressed according to patient parameters). Acute-phase rehabilitation interventions were delivered by physical therapists in 13 of the 21 studies. In other studies, the intervention was delivered by research personnel or was not reported. All acute-phase rehabilitation interventions were delivered in-person, where reported. In addition to in-person delivery, three studies had a self-guided home-based component,32,78,84 and one study had a remote (via app or telephone) component.67 Ten studies were delivered exclusively in an inpatient rehabilitation setting.42,46,47,49,72,73,80,83,85,86 Three acute-phase rehabilitation interventions were compared in different settings.32,40,67 Three studies reported the destination to which patients were discharged (e.g., home, community hospital, long-term care facility) and not the setting in which rehabilitation was provided, per se.35,63,64
Description of the Postacute Rehabilitation for TKA Evidence
Thirty-two studies (31 RCTs and 1 NRCS) evaluated postacute phase rehabilitation in 5484 patients (summarized in Figs. 4–6). Of these, 17 RCTs evaluated novel (hypothesized better) rehabilitation programs versud standard care (variously defined) or alternative rehabilitation program, one RCT evaluated two active programs hypothesized to be similar effects,30 one NRCS evaluated a comparatively similar rehabilitation program delivered with varying intensity/timing,71 six RCTs evaluated comparatively similar rehabilitation programs delivered in different settings or by different personnel,26,39,57,59,70,79 and seven RCTs evaluated comparatively similar rehabilitation programs with or without an adjunctive modality.34,36,48,65,66,76,83
Postacute phase rehabilitation interventions were initiated after discharge between 2 and 8 wks after TKA surgery and subsequently continued up to 6 mos. Most studies had some form of active comparison, even when described as “usual” or “standard care.” Studies varied in their definitions of standard practice, and in some cases, usual care was no further rehabilitation (or was not reported).
We were able to code at least some rehabilitation content in 57 of the 66 arms of the 31 studies. Most rehabilitation interventions included exercises to address the goal of strength (27/31 studies, 49/66 arms) and flexibility (25/31 studies, 44/66 arms), followed by task-specific training (21/31 studies, 34/66 arms), patient education (20/31 studies, 29/66 arms), and balance-motor-learning-agility (17/31 studies, 25/66 arms). Only half the studies included exercises targeted at aerobic endurance (15/31 studies, 24/66 arms).
We found 14 studies that included an adjunctive modality in combination with the rehabilitation program (i.e., heat, cold, NMES, TENS, biofeedback devices, dry needling, massage, mobilization, mindfulness/stress reducing activities, and complementary and alternative therapies). Of these, six RCTs were designed to evaluate the added benefit of an adjunctive therapy (NMES: 2, biofeedback: 1; dry needling: 1; and Tai chi: 1).
We found 24 studies that reported some form of progression, of which 16 were assessed by clinical experts on our team as appropriate in at least one arm of the study. One study compared a high-intensity progressive rehabilitation versus low-intensity rehabilitation without progression.29 Eight other studies had appropriate progression coded in one arm and no progression in the comparison arm.30,31,38,39,45,52,55,70 Postacute rehabilitation interventions were delivered by physical therapists in 28 of the 32 studies. Four remaining studies did not report who delivered the rehabilitation intervention.36,48,50,76 Three studies had either additional personnel deliver one arm of the intervention (an athletic trainer for one arm in Piva et al.,70 a Tai Chi instructor for one arm in Li et al.48) or a component of the intervention in combination with the physical therapist (a psychologist delivered the cognitive behavioral component in Cai et al.34).
Most of the postacute rehabilitation interventions were delivered to patients in person (n = 30). Li et al.50 had no in-person component and compared remote patient education promoting physical activity (by telephone, once a month for 6 mos) to no patient education. Moutzouri et al.61 compared two patient self-guided interventions intended to be performed by patients independently at home (focal sensorimotor exercise training vs. functional exercise training). Several studies had self-guided components in addition to in-person supervised rehabilitation in either or both arms or compared some form of supervised rehabilitation to self-guided rehabilitation in the comparison arm. Four studies included some form of remote rehabilitation, delivered either by telephone (n = 2), video (n = 1), or Web (n = 1).
Interventions were delivered in various settings (and often, in combinations of settings). Ten studies evaluated one or both rehabilitation arms in outpatient settings exclusively.27,30,31,45,51,65,66,71,76,83 Four studies evaluated one or both rehabilitation arms at home exclusively.50,56,59,62 Six studies evaluated rehabilitation programs delivered in both outpatient and home settings in one or both arms29,38,41,52,55,68 and six studies evaluated rehabilitation programs that were delivered in the outpatient setting in one arm and to patients in their home in the other arm.26,36,39,57,79,81 In the study by Schache et al.,75 the intervention was delivered in the acute and outpatient setting in both study arms, and in the study by Kauppila et al.,43 the intervention was delivered in the acute, outpatient, and home setting in both study arms. In the study by Monticone et al.,60 the intervention was delivered in a nonacute inpatient facility in both study arms. In the study by Piva et al.,70 the intervention was delivered in a gym setting (for group classes) in one arm, compared with an outpatient setting in the other arm. Two studies did not report the setting in which the rehabilitation was delivered.34,48 Andersen26 focused on the comparison of the setting of rehabilitation and personnel exclusively and provided no details on rehabilitation content.
Comparative Effectiveness of Rehabilitation Interventions
Evidence from 53 studies suggests comparable outcomes of pain, strength, activities of daily living (ADL), and quality of life (QoL, low SoE for all) between rehabilitation groups evaluated (Tables 1, 2). Furthermore, comparable outcomes with insufficient evidence were found on the impact of rehabilitation on knee range of motion (ROM) and satisfaction with care. While low SoE suggests comparable risk of harms among rehabilitation programs delivered in the postacute phase, there is insufficient evidence to assess the risk of harm from rehabilitation in the acute phase after surgery. Rehabilitation programs and reported outcomes were too heterogeneous to explore whether effects varied by the presence of intervention content or mode of delivered (i.e., personnel, setting, progression).
TABLE 1 -
Evidence profile: Acute rehabilitation versus various controls for TKA
||No. Studies (Participants)
|Body structure and function
|Activity and participation
|Other patient-reported outcomes
||Satisfaction with care
||Similar satisfaction with care
||Consistency unknown (single study)
||NA (single study)
||Need for postoperative procedures
||Harms from rehabilitation
NA, not applicable; RoB, risk of bias.
TABLE 2 -
Evidence profile: Postacute rehabilitation versus various controls for TKA
||No. Studies (Participants)
|Body structure and function
|Activity and participation
|Other patient-reported outcomes
||Satisfaction with care
||Consistency unknown (single study)
||NA (single study)
||Need for postoperative procedures
||Consistency unknown (single study)
||NA (single study)
||Harms from rehabilitation
NA, not applicable; RoB, risk of bias.
Body Structure and Function Outcomes
Fourteen studies reported on body structure and function outcomes after rehabilitation delivered in the acute phase after surgery (symptoms, pain, ROM, muscle strength, energy and vigor, and emotional functioning).28,32,40,46,49,53,54,67,72,73,78,80,84,85
Twelve studies reported pain data using three different measurement instruments (the pain components of EuroQol-5 dimension and The Western Ontario and McMaster Universities Arthritis Index [WOMAC], and a pain visual analog scale).32,40,46,49,53,54,67,72,73,78,80,84 Most studies (n = 10) found no difference in pain data between comparison groups at 3–24 mos after TKA.32,40,46,53,54,67,73,78,80,84 Two studies reported reduced pain in their respective intervention groups.49,72 Li et al.49 reported pain on a visual analog scale (0–10, lower is better) and found that patients randomized to gait training and usual care reported significantly lower pain compared with patients randomized to usual care at 6 mos after TKA (MD = −2.4, 95% confidence interval [CI] = −2.7 to −2.2). Rockstroh et al.72 (2010) also found reduced pain on the visual analog scale among patients randomized to physiotherapy with adjunctive microcurrent therapy versus physiotherapy alone (MD = 2.0, 95% CI = 1.4 to 2.6) at 3 mos after TKA.
Nine studies reported ROM data from various outcome measures, including active and passive knee ROM for extension and flexion of the knee joint.32,40,46,49,67,73,78,84,85 Most studies (n = 7) reported comparable ROM between arms at follow-up measured between 3 and 24 mos after TKA. Two studies reported increased ROM in their respective intervention groups.49,73 Sattler et al.73 reported improved knee flexion ROM at 4 mos among patients randomized to the pedaling-based protocol (i.e., ROM exercise was a core component of the intervention) compared with patients randomized to the nonpedaling multiexercise protocol (MD = 2.7, 95% CI = 2.6 to 7.9) at 4 mos after TKA. Li et al.49 (2017) also reported improved knee extension and flexion among patients randomized to early gait training and usual care compared with usual care alone at 6 mos after TKA.
Four studies or fewer reported data on symptoms (e.g., stiffness, n = 4),40,46,53,54 strength (n = 3),67,78,80 and emotional functioning (n = 2)28,78; no study reported data on energy or vigor. With respect to symptoms, experience of symptoms was comparable among intervention and control groups at 3–12 mos after TKA. All three studies that reported data on muscle strength (including isometric and isokinetic knee extension and knee flexion strength, quadricep and hamstring strength and torque, and percent quadriceps activation) reported significant improvement for at least one measure of strength with the intervention rehabilitation arm. Of the two studies to report data on emotional functioning (from the mental health scale of the SF-36) Avramidis et al.28 found significant improvements among patients randomized to adjunctive TENS in combination with physiotherapy compared with physiotherapy alone at 3 mos (although these differences were no longer significant at 12 mos after surgery).
Twenty-six studies reported on body structure and function outcomes (symptoms, pain, ROM, strength, energy and vigor, and emotional functioning).26,27,29–31,34,36,38,41,44,45,48,50–52,55–57,59,60,62,65,66,75,76,79,81
Twenty-two studies reported data on pain, using six different outcome measures assessed between 3 and 12 mos after surgery.27,30,31,34,36,38,41,45,48,50–52,56,57,59,60,62,65,66,75,81,83 Most studies (n = 17) found no difference in pain data between comparison groups at 3–12 mos after TKA.27,30,31,38,41,45,48,50,51,56,57,59,65,66,75,81,83 Five studies reported reduced pain in their respective intervention groups,34,36,52,60,62 although intervention programs were diverse (cognitive behavioral therapy and standard care vs. standard care34; neuromuscular electrical stimulation and exercise versus exercise alone36; elastic resistance exercise training versus standard care52; home-based functional exercises and kinesiophobia training versus in-person usual rehabilitation60; early self-managed focal sensorimotor exercise training vs. function exercise training62).
Eleven studies reported data on symptoms using the stiffness component of the WOMAC and the symptoms component of The Knee injury and Osteoarthritis Outcome Score (KOOS).27,31,36,45,56,57,59,60,65,75,83 Nine studies observed no differences between groups at follow-up ranging from 3 to 12 mos after TKA, and two studies reported significant differences between groups. Demircioglu et al.36 reported symptoms using the stiffness component of the WOMAC (0–100, larger is worse) and found that patients randomized to exercise and adjunctive NMES reported experiencing fewer symptoms than patients randomized to exercise alone at 3 mos after TKA (MD = −5.0, 95% CI = −9.5 to −0.5). Monticone et al.60 reported symptoms using the symptoms component of the KOOS (0–100, larger is better) and found that patients randomized to home-based functional exercises and kinesiophobia training reported experiencing fewer symptoms than patients randomized to a less intensive rehabilitation exercise program without kinesiophobia training at 6 and 12 mos after TKA.
Of the 15 studies26,29–31,36,38,43,48,55,59,62,66,75,79,81 that reported ROM data from various outcome measures, including active and passive knee ROM for extension and flexion of the knee joint, 13 reported comparable ROM between arms at follow-up measured between 3 and 12 mos after TKA across the various interventions and comparisons. Moutzouri et al.61,62 showed significant improvements in active knee ROM flexion among patients randomized to early self-managed focal sensorimotor exercise training compared with patients randomized to functional exercise training. Li et al.48 found significant differences between groups in extension ROM (but not flexion ROM) among patients randomized to Tai Chi compared with patients randomized to rehabilitation at 3 mos after TKA.
Fourteen studies29–31,38,41,43,55,56,59,62,66,75,76,81 reported strength data from various outcome measures including isometric and isokinetic knee extension and knee flexion strength, and quadricep and hamstring strength and torque, among others. Four41,62,76,81,87 of the 14 studies reported significant differences between groups (in at least one measure reported). Heikkilä et al.41 (2017) reported patients randomized to home-based rehabilitation showed increased knee extension (MD = 70, 95% CI = 33 to 108) and knee flexion strength (MD = 30, 95% CI = 17 to 43) compared with patients randomized to usual care (no additional rehabilitation after discharge) at 14 mos after TKA. Moutzouri et al.61,62 reported that patients randomized to early self-managed focal sensorimotor exercise training had improved peak force (N) compared with patients randomized to functional exercise training (MD = 12.1, 95% CI = 3.9 to 20.2). Vuorenmaa et al.81 reported that patients randomized to home exercise had significantly improved isometric knee flexion (but not extension; MD = NR; P = 0.009) compared with patients randomized to control (no additional guidance after baseline measurements). Shanb and Youssef76 reported patients randomized to active exercise training and biofeedback had significantly improved performance of quadricep isometric peak torque at 4 mos after surgery (P = 0.01).
Eight studies29,36,38,48,57,66,75,81 reported on emotional functioning data from the mental health, emotional role functioning, and social functioning component scales of the SF-36. All but one study48 reported comparable results among groups on measures of emotional functioning between 3 and 12 mos after TKA. Li et al.48 reported significant improvements in mental health among patients randomized to adjunctive Tai Chi compared with rehabilitation alone at 3 mos after TKA (P = 0.03).
Activity and Participation Outcomes
Fifteen studies reported on activity and participation outcomes (physical function and activities of daily living, transfers, balance, mobility, and timed up and go [TUG]).28,32,35,40,46,47,53,54,63,67,73,78,80,84,86
Eleven RCTs reported data on patient-reported physical function and ADLs using various outcome measures at follow-ups between 3 mos and 2 yrs after TKA surgery.28,32,35,40,46,53,54,63,73,78,84 Eight studies found no difference between groups in terms of patient-reported function and ADL and three studies28,35,40 reported significant differences in between groups. Harmer et al.40 (2009) reported physical function data using the function component of the WOMAC and found patients randomized to water-based rehabilitation reported significantly greater improvements in physical function compared with patients randomized to land-based rehabilitation (P = 0.04). Chan et al.35 (2018) reported physical function and ADL data using the ADL Oxford Knee Score, the physical component of the SF-36, and the function component of the Knee Society Clinical Rating System and observed that while patients discharged home had lower ADL measured on the Oxford Knee Score, they had higher physical function as rated on the SF-36 and Knee Society Rating Scales. Avramidis et al.28 found that patients randomized to physiotherapy combined with adjunctive TENS reported better knee function (based on the physical component of the SF-36 and function component of the Knee Society Clinical Rating System scales) at 3 and 12 mos after TKA.
Seven studies32,40,47,73,78,80,84 reported on various outcome measures of mobility (the 6-min walk test, 10- and 15-meter walk tests, stair climb tests, Functional Ambulation Category system, and Iowa Ambulation Velocity Scale) and found no difference between groups in five studies 3–12 mos after TKA and significant differences between groups in two studies. Li et al.47 (2014) reported improved distance of 6-min walk test (meters, larger is better) among patients randomized to robot-assisted training compared with control at both 6 mos (MD = 63.6, 95% CI = 48.4 to 78.8) and 12 mos (MD = 73.4 meters, 95% CI = 60.4 to 86.4) after TKA, but no difference in Functional Ambulation Category. Stevens-Lapsley et al.78 reported improved performance of the 6-min walk test (MD = 46.8, P < 0.05) and stair climb test (seconds, smaller is better; MD = −3.3, P < 0.05) among patients randomized to standard rehabilitation with adjunctive NMES compared with standard rehabilitation alone.
Of the five studies67,73,78,80,84 reporting data on the TUG test, three studies73,80,84 reported no differences between groups, and two studies67,78 reported significant improvements in the performance of the TUG test among patients receiving interactive virtual rehabilitation (vs. conventional outpatient physical therapy)67 and standard rehabilitation plus adjunctive NMES (vs. standard rehabilitation alone),78 respectively.
Two studies reported data on transfers.47,80 Tsukada et al.80 observed no differences between groups at follow-up 3 mos; Li et al.47 found that patients randomized to robot-assisted training had improved performance of transfers at 6 and 12 mos after TKA. Two studies reported balance data. Li et al.47 reported balance data from the Berg Balance Scale and found significant difference between compared groups at 6 or 12 mos after TKA among patients randomized to robot-assisted training compared with those who received traditional rehabilitation training. Zapparoli et al.86 reported significantly fewer falls/near fall in the past year among patients randomized to specific motor imagery and rehabilitation compared with rehabilitation alone at 2 yrs after surgery.
Twenty-seven studies reported on activity and participation outcomes (physical function and activities of daily living, transfers, balance, mobility, and TUG).26,27,29–31,34,36,38,41,43,45,48,50–52,55–57,59,60,62,65,66,75,79,81,83
Twenty-two studies reported data on patient-reported physical function and ADLs using various outcome measures at follow-up times between 3 and 12 mos after TKA surgery.27,36,38,39,45,48,51,52,55–57,59,60,62,65,66,68,70,71,75,81,83 Fifteen studies reported no difference in patient-reported function and ADL measures between groups. Seven studies found significant differences between groups, although the direction of effect was not consistent whether the intervention favored more or less intensive forms of rehabilitation.27,39,48,51,52,56,62
Sixteen studies reported on various outcome measures of mobility including the 6-min walk test, 10-, 15-, and 40-meter walk tests, stair climb tests among others.26,29–31,38,41,43,48,51,55,56,59,66,68,75,81 Most studies (n = 11) reported no difference in mobility among groups at follow-up times ranging from 3 to 12 mos after TKA. Five studies reported significant differences between groups for at least one mobility outcome measured.31,41,48,51,68
Ten studies or less reported data on the TUG (n = 10), transfers (n = 7), and balance (n = 5) and generally found comparable outcomes among groups with the exception of two studies.51,52 Liao et al.51 (2015) reported that patients randomized to functional plus balance rehabilitation completed significantly more sit to stand compared with those randomized to functional rehabilitation alone (P < 0.0001). Liao et al.52 (2020) reported that patients randomized to elastic resistance exercise training performed significantly better on the TUG test (P = 0.002) and the sit-to-stand test (P = 0.001) and had significantly improved balance (based on the forward reach test and single-leg stance test) compared with those randomized to standard care.
Other Patient-Reported Outcomes
Ten studies reported on other patient-reported outcomes (QoL, patient satisfaction with care, and patient global assessments).32,35,37,42,46,54,64,72,73,78 Of the 10 studies,32,35,37,42,46,54,64,73,78,85 findings were mixed with five studies reporting comparable results among groups32,54,64,73,85 and five studies reporting significant differences among groups.35,37,42,46,78 Three studies reported data on satisfaction with care32,46,53; only Buhagiar et al.32 found that patients randomized to hospital inpatient rehabilitation reported significantly higher satisfaction with care compared with patients randomized to the home program. Finally, only one study reported on QoL and found that patients randomized to physiotherapy combined with adjunctive microcurrent (TENS) reported clinically significant improvements compared with patients randomized to physiotherapy alone at 3 mos after TKA.72
Fourteen studies reported other patient-reported outcomes (QoL, patient satisfaction with care, and patient global assessments).26,27,29–31,36,43,45,56,57,59,60,65,70
Twelve studies reported QoL data using the QoL component of the KOOS and the total SF-36.26,27,31,36,43,45,56,59,60,65,70,83 While most studies (n = 10) reported comparable QoL among rehabilitation arms at follow-up between 3 and 12 mos, two studies reported significant differences between groups.26,60 Both Andersen26 and Monticone et al.60 reported data on the QoL component of the KOOS and found that patients randomized to intervention group (technological assisted rehabilitation; home-based functional exercises and kinesiophobia training) had improved QoL compared with their respective usual care groups.
Eight studies provided data on patients’ self-reported global assessment of their health using five different measurement instruments assessed between 3 and 12 mos after TKA surgery.27,29,30,36,43,57,70,83 Most studies (n = 6) reported comparable results between groups with the exception of two studies.27,36 One study reported data on satisfaction with care and found no differences between patients randomized to in-home telerehabilitation compared with standard home rehabilitation.59
Healthcare Utilization Outcomes
Two studies reported on the need for manipulation under anesthesia (MUA) to address stiff knee after acute rehabilitation after TKA32,40 and observed comparable events among groups. Three studies32,53,54 reported other healthcare utilization data, including the number of patients readmitted for limited ROM, time lost from work, and the number of outpatient physical therapy sessions required. Studies reported no significant differences between groups in these measures.
One study29 reported data on the need for postoperative procedures after rehabilitation after TKA surgery and observed few events in which patient needed MUA to address stiff knee, with comparable proportions of patients requiring MUA between groups.
Harms From Rehabilitation
No study reported adverse events from participating in the acute rehabilitation programs.
Among studies that reported on harms, most (n = 10/17) reported no adverse events associated with the diverse rehabilitation programs.30,41,43,45,50,52,56,62,65,66 Harms that were reported were generally low severity, uncommon, and comparable between groups.
No studies reported subgroup analyses or, more specifically, formally analyzed possible heterogeneity of treatment effects, that is, statistical tests for whether the comparative effect of rehabilitation versus its various comparators differed in one subgroup of patients versus another (e.g., patients with higher vs. lower measures of strength, flexibility, function, etc. at baseline).
Based on evidence from 53 studies involving 11,533 patients, it remains unclear which rehabilitation program should be offered to patients who have undergone TKA or what specific attributes of programs are most effective in achieving optimal patient outcomes. Studies had moderate risk of bias at best largely due to the challenge of blinding of rehabilitation interventions. We found low SoE for comparable effects among diverse rehabilitation programs in terms pain, ROM, and ADL outcomes. We found low SoE that rehabilitation in the acute phase (but not the postacute phase) may lead to increased strength and low SoE that rehabilitation in the postacute phase may not increase risk of harms (no evidence on harms was reported in the acute phase). Compared with a variety of (usually less intensive) comparators, we found some evidence to suggest that rehabilitation programs offered in the acute phase may result to similar satisfaction with care and rehabilitation programs delivered in the postacute phase may result in similar QoL. We found insufficient evidence on the impact of rehabilitation on QoL for acute rehabilitation, satisfaction with care for postacute rehabilitation, and the need for postoperative procedures for both acute and postacute rehabilitation. Finally, we found low SoE to suggest that the risks of harms from postacute rehabilitation interventions are low and comparable across groups and no evidence on harms in studies that reported effects of acute rehabilitation interventions. These conclusions are striking given rehabilitation is the standard practice to achieve optimal range of motion, reduce fibrosis and scar formation after TKA.
This lack of evidence to adequately guide rehabilitation practice for TKA parallels those reported in a companion article that reviewed the comparative effectiveness of rehabilitation interventions for patients who have undergone THA13 but is even more striking given the substantially larger number of patients that undergo TKA versus THA annually (680,150 vs. 370,770 based on 2014 estimates)88 and the fact that the evidence base for TKA is more than 3 times as large as THA (53 vs. 16 studies).
The factors contributing to this lack of evidence are multifaceted and are reported in more detail in our companion THA article13 as well as a commentary on the challenges of using evidence to inform a clinical practice guideline on rehabilitation for TKA.89 Briefly, these factors include the:
- heterogeneity of the sample (e.g., characteristics of sample that make them more or less likely to respond to rehabilitation)90
- complex nature of rehabilitation programs
- heterogeneity of intervention content and methods of delivery across studies (e.g., timing, intensity, personnel, setting)
- lack of standardized and thorough reporting of intervention content (for both “treatment” and “control” groups) and methods of delivery across studies
- heterogeneity of outcomes evaluated across studies and outcome measures used to assess specific outcomes
- small sample sizes (particularly given the comparisons of two or more active intervention groups that require larger samples to identify a statistically significant effect if the hypothesized difference between groups is relatively small)
To be concrete, the evidence included in this review consisted of completely unique interventions (i.e., each study had different content delivered in different ways) assessed using a total of 15 outcomes domains on 142 different outcome measures at diverse time points ranging from 3 mos to 2 yrs. The most common outcome, pain, was only reported in 64% (n = 34) of the included studies. Intervention descriptions ranged from short phrases (“inpatient rehabilitation”) to multipage written and visual protocols. Based on the state of this evidence (compared with the complexity of stakeholder questions), it is clear that a fundamental shift is needed in trial design, funding, and reporting to generate future evidence that is sufficient to guide rehabilitation practice. At minimum, this would include designing interventions using some form of standardized taxonomy to define intervention content (such as the taxonomy used to code content in this review),91 transparently reporting the complete content of interventions (e.g., using the Template for Intervention Description and Replication checklist to ensure comprehensive reporting of all intervention elements),92 and evaluating the impact of interventions using a minimum core set of outcomes evaluated across all trials.93,94 A more in depth description of the next steps needed in rehabilitation research based on the current state of the evidence can be found in the THA and Jette et al. articles.13,89
Strengths and Limitations of the Review
We used a comprehensive strategy to ensure that our literature search was complete and checked references of included studies to ensure that we did not systematically miss studies. Although we restricted the evidence base to the past 15 yrs, we made this decision in collaboration with our stakeholders who felt this was justified given changes in orthopedic surgery practices and rehabilitation protocols in the early 2000s. An important strength of this review was the thorough, standardized, and independent coding of the rehabilitation interventions using a comprehensive taxonomy empirically developed by experts in the field. To our knowledge, this is the most detailed coding of interventions in SR of rehabilitation after TKA to date. For each intervention and comparator evaluated, we independently coded the specific exercises included in the program and goals these exercises sought to address (e.g., strength, flexibility). Standardized coding of the rehabilitation interventions offers an important step forward in synthesizing rehabilitation evidence by establishing a common language of the active ingredients contained within interventions to compare across studies. In the absence of quantitative synthesis, these codes at a minimum point to the diversity of rehabilitation interventions being evaluated (hopefully making it clear that one-word reporting of “rehabilitation” should no longer be acceptable as an intervention description) and provide a starting bases for decision makers seeking to replicate or build from successful individual studies. While we were unable to link these codes to intervention outcomes (due to the large number of intervention components combined with the sparse reporting of specific outcomes across studies), the thorough process of coding each program provided insights into the general composition of rehabilitation programs studied and what components were more or less commonly used across studies. It also revealed the vast creativity and heterogeneity of the rehabilitation interventions and the lack of reporting or standardization of “standard care” comparators. A limitation of our synthesis is that we did not capture data on timing, intensity, or dosage of interventions (e.g., challenge of the exercise, duration of the session in minutes, duration of the program in days/weeks, number of sessions).
In conclusion, many questions remain regarding the best rehabilitation management of patients with osteoarthritis who have undergone a TKA due to the extensive heterogeneity of interventions and outcomes across studies. An important and imminent shift in the research agenda is needed to advance the science and ensure the rehabilitation offered to more than half a million Americans who undergo TKA each year is evidence based.
The authors thank David W. Niebuhr, MD, MPH, MSc, our AHRQ Task Order Officer; members of the Key Informant and Technical Expert Panels, reviewers of our overall review (all listed in the AHRQ full report); Jennifer Racine-Avila, MBA, for early feedback and development of the protocol; Carol A. Oatis, PT, PhD, for sharing her taxonomy and providing important conceptual feedback in its application; and Shivani Mehta, BA, a research associate who played a role in conduct of the overall review.
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