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High Risk of Further Surgery After Radial Head Replacement for Unstable Fractures: Longer-term Outcomes at a Minimum Follow-up of 8 Years

Cristofaro, Caroline D. BSc, MBChB; Carter, Thomas H. BSc(Hons), MBChB, MRCSEd; Wickramasinghe, Neil R. MBChB, MRCSEd; McQueen, Margaret M. MD, FRCSEd(Orth); White, Timothy O. MD, FRCSEd(Tr&Orth); Duckworth, Andrew D. MSc, FRCSEd(Orth), PhD

Author Information
Clinical Orthopaedics and Related Research: November 2019 - Volume 477 - Issue 11 - p 2531-2540
doi: 10.1097/CORR.0000000000000876
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Complex, unstable fractures of the radial head, including Mason type III and IV injuries, are a unique surgical challenge because of their association with other injuries around the elbow and forearm, and they are often associated with instability [16]. The aim of treatment is to restore elbow and/or forearm stability, and restoring radiocapitellar contact is essential [7, 39]. Partial or complete radial head excision is possible when these injuries are not associated with instability [2, 4, 23, 25, 27]. Open reduction and internal fixation (ORIF) [11, 26, 29, 40, 45] or prosthetic replacement [3, 6, 10, 14, 20, 38, 46] are otherwise recommended. Unstable fractures treated with ORIF are susceptible to early reoperation, nonunion, and inferior outcomes [12, 30, 34, 40]. Two prospective randomized trials have supported replacement over ORIF to treat patients with unstable fracture patterns [10, 41], and two recent meta-analyses [15, 44] have reported that replacement has superior postoperative outcomes and lower complication rates than ORIF.


The evidence for the treatment of acute complex radial head fractures with radial head replacement predominantly consists of short- to mid-term follow-up studies that are limited regarding the long-term outcome [28], with a wide range of reporting criteria used in various studies. This has led some to suggest that the current data underestimate the true percentage of implant loosening and reoperation because smaller studies reporting greater complications are less likely to have been published [32]. Another study subsequently recommended a minimum follow-up period of at least 3 years to accurately record complications, specifically early failure requiring reoperation [32]. There is currently a lack of long-term follow-up data in this patient group, particularly in terms of implant removal rates and patient reported outcomes.

We therefore asked: (1) What proportion of patients undergo revision or implant removal after radial head replacement? (2) At a minimum of 8 years of follow-up, what are the patient-reported outcomes (QuickDASH, Oxford Elbow Score, and EuroQol-5D)? (3) What factors are associated with a superior long-term patient-reported outcome, according to the QuickDASH?

Patients and Methods

Study Design and Setting

Permission to access patient records and collect outcome data was granted by our health board ethics committee, and the study was registered with the local Musculoskeletal Quality Improvement Project group. We retrospectively analyzed a longitudinally maintained trauma database at our study center between September 1994 and September 2010. We reviewed previously collected data because this study builds on our previous study reporting on short-term outcomes and identifying risk factors associated with secondary surgery after radial head replacement [17].


We included all skeletally mature patients who underwent surgery to manage a radial head fracture during the 16-year study period. We excluded patients who underwent primary radial head excision, primary ORIF, and those in whom fixation had failed and who subsequently underwent secondary radial head replacement. The initial diagnosis was made by examining radiographs and CT images, if these tests were performed and were available.

Demographics, Description of Study Population

A total of 119 patients were identified, of whom 53% (63) were women and 47% (56) were men, with a mean age of 50 years (15 to 93 ± 19 years). One or more comorbidities were documented in 56% (66 of 119 patients). The most frequent mechanism of injury was a fall from standing height (58%, n = 69), followed by a fall from height (23%, n = 27), motor vehicle collision (9%, n = 11), assault (3%, n = 4), sports (4%, n = 5), and other (3%, n = 3).

Regarding fracture type, 91% (108) were radial head fractures and 9% (11) were radial neck fractures. Three percent of patients (3) had Mason Type 2 fractures (radial head: n = 3; radial neck: n = 0), 74% (88) had Mason Type 3 fractures (radial head: n = 78; radial neck: n = 10), and 23% (28) had Mason Type 4 fractures (radial head: n = 27; radial neck: n = 1). One hundred thirty-three associated injuries were documented in 69% (82 of 119) of patients. Twenty-four percent (28 of 119) of patients had an associated elbow dislocation; 68% (19 of 28) of patients had a dislocation that was part of a terrible triad injury and 7% (two of 28) of patients had an associated fracture of the proximal ulna (excluding the coronoid). Of 119 patients, 27% of patients (32) had an associated fracture of the proximal ulna. Nine percent of patients (11 of 119 patients) had an isolated fracture of the coronoid, and 3% of patients (three of 119) had an Essex-Lopresti-type injury.

Accounting for All Patients

Eligibility was assessed in 157 patients (Fig. 1). After the exclusion criteria were applied, we omitted 38 patients because of primary excision (13%, n = 21), primary internal fixation (10%, n = 15), and secondary radial head replacement (1%, n = 2). Nineteen of the remaining 119 patients (16%) were deceased at the time we collected outcome scores at a median follow-up of 11 years (range 8 to 24 years). Of the remaining 100 patients, 20 (20%) were uncontactable, allowing collection of outcome scores from 80 patients (80% of the contactable cohort; 67% of the total cohort). All efforts were made to obtain correct contact details for all patients in the study group by contacting their general practitioner and/or next of kin if required. Patients were deemed uncontactable if no response was achieved after three consecutive telephone calls on different days of the week and no further contact information was available from alternative sources.

Fig. 1:
This STROBE study flow chart demonstrates the selection and flow of patients.

Description of Experiment, Treatment, or Surgery

Details of the management and postoperative protocols, along with the surgical techniques used, were reported in our original study [17]. All but two implants were uncemented, loose-fitting, monopolar prostheses, of which 86% (102) were metallic and 14% (17) were silastic. Implants were only cemented if they appeared unstable within the proximal radius. Silastic implants were used in the earlier years of the series, with metallic implants used from 2000 onward. All procedures were supervised or performed by many prior to experienced consultant orthopaedic trauma surgeons. As stated in our previous study, the indication for surgery was a mechanical block to forearm rotation or severe displacement or comminution of the radial head fracture that was associated with elbow or forearm instability. ORIF was performed if the surgeon thought the radial head could be reconstructed, with replacement otherwise performed. Radial head excision alone was performed if the radial head was removed and there was no evidence of instability.


Patients were discharged after a short hospital stay and were immobilized for 2 to 3 weeks. They then began active range of motion exercises. Postoperative physiotherapy for any residual functional deficit or stiffness was arranged at the discretion of the operating surgeon.

As per our department policy, implants were removed when the patient had pain and/or reduced ROM thought to be associated with the implant. Implants were also routinely removed as part of an arthrolysis procedure for stiffness. Revision procedures were performed due to residual elbow instability. The final decision to remove an implant was made by the treating surgeon.

Variables, Outcome Measures, Data Sources, and Bias

A search of electronic hospital records identified all patients who had died since discharge. Nineteen patients had died at the point of outcome score collection. Of the remaining 100 patients, 80 were contacted (67% of the total cohort). Patient-reported outcomes were collected through structured telephone interviews performed by two of the authors (THC, CDC), neither of whom was involved with patient care.

The primary outcome measure was the QuickDASH score [24], which has been validated for completion over the telephone [35]. Secondary outcome measures were the Oxford Elbow Score [13] and EuroQol-5D score [5]. We also collected pain scores measured on a scale of 0 to 10, with 10 indicating the worst possible pain, along with details on time (in weeks) to return to work and sports. Further surgical interventions that might have been performed elsewhere, including removal, revision, arthrolysis, or ulnar nerve decompression, were also documented.

Statistical Analysis, Study Size

Normality was assessed using the Shapiro Wilk test. Patient age, the QuickDASH and the Oxford Elbow Score were found to be normally distributed, with the EuroQol-5D, pain and return to activity having a skewed distribution. We used an independent samples t-test to analyze parametric, continuous data, with a Mann-Whitney U test for nonparametric, continuous data. We used a one-way ANOVA to compare parametric, continuous data among several categories, using the Kruskal-Wallis test for nonparametric data. Categorical binary data were analyzed using either the chi-square test (all observed frequencies in each cell > 5) or the Fisher’s exact test (one cell had an observed frequency of ≤ 5). Spearman’s correlation coefficient was used to determine the correlation between two continuous variables. A linear regression analysis was used to determine predictors of the primary outcome (QuickDASH score) when controlling for baseline patient (age, sex, and comorbidities) and fracture (fracture location and associated injury) characteristics, revision or removal of the prosthesis, and prosthesis type. Two-tailed p values were calculated, and significance was set at p < 0.05, with 95% confidence intervals presented where appropriate. Kaplan-Meier analysis and a life table were used to examine implant survival as a function of time. Data were analyzed using IBM SPSS software, version 23.0 (IBM Corp, Armonk, NY, USA).


Survivorship Analysis: Rate of Reoperation

The median time to revision or removal, death or last follow-up for the survivorship analysis was 99 months (range 1 to 240 months). Thirty of 119 patients (25%) underwent reoperation, with three patients undergoing revision and 27 patients undergoing prosthesis removal at a median of 7 months (range 0 to 125 months). Twenty-one of these procedures (70%) occurred within 1 year after implantation (Fig. 2). Kaplan-Meier analysis (Fig. 3) and a life table survivor analysis (Table 1) demonstrated a cumulative implant survival rate of 71%, with a 1-year survival rate of 79% (95% CI 78 to 80), a five-year rate of 73% (95% CI 71 to 75) and a 10-year rate of 71% (95% CI 67 to 75). The Kaplan-Meier curve demonstrated an initial sharp decline in survivorship within postoperative year 1, followed by a plateau phase (Fig. 3) with only an 8% decline in survivorship over the subsequent 9-year period.

Fig. 2:
This graph details the number of patients who underwent revision or replacement of the radial head prothesis at 10 years after implantation.
Fig. 3:
A Kaplan-Meier survival curve for the study cohort, with revision or removal of implant being defined as failure.
Table 1.:
A life table for survival analysis over time

The most common reason for removal was persistent stiffness with or without pain (40%, n = 12 of 30; Table 2). Symptomatic painful loosening was the second most common indication for further surgery (20%, n = 6 of 30; Fig. 4). Fifty-three percent of patients (9 of 17) with silastic implants underwent further surgery for revision or removal, compared with 21% (21 of 102) of patients with metallic implants. An infection developed in 3% (four of 119) patients postoperatively. Three infections were superficial and were treated with oral antibiotics only. One was deeper and treated with intravenous antibiotics, débridement, and removal of the implant for infection control. Five percent (six of 119) of patients underwent arthrolysis for persistent stiffness at a median of 7 months (range 2 to 11 months). Two percent (two of 119) of patients underwent further surgery to decompress and transpose the ulnar nerve.

Table 2.:
Reasons for revision or removal of the radial head prosthesis
Fig. 4:
These (A) lateral and (B) AP radiographs of a 56-year-old woman 18 months after surgery demonstrate implant loosening with lysis around the stem.

Long-term Patient-reported Outcome Scores After Treatment

Of the 80 patients who were contacted at a median of 11 years (range 8 to 24 years) after injury, the mean QuickDASH score was 13 ± 14 (Table 3).

Table 3.:
Patient-reported outcomes after surgery

Of 80 patients, 30% (24) were retired or unemployed at the time of their injury. Forty-six of the remaining 56 patients (82%) returned to work at a median of 6 weeks after injury (range 0 to 100 weeks). Twenty-six of 80 patients (33%) did not play sports before their injury. Seventeen of the remaining 54 patients (31%) were able to return to sports at a median of 20 weeks after injury (range 4 to 104 weeks). Patient-reported outcomes did not differ between patients undergoing secondary surgery (n = 19) and those who did not (n = 61) (all p > 0.05; Table 3). There was also no difference in the patient-reported outcomes at a minimum follow-up of 8 years between patients who had silastic implants (n = 9) and those who did not (n = 71) (all p > 0.05).

Factors Associated with Longer-term Outcome according to the QuickDASH

In the linear regression analysis controlling for age, sex, comorbidities, associated injuries, and fracture location, prosthesis revision or removal (p = 0.466) and prosthesis type (p = 0.553) were not independent predictors of the QuickDASH score at a minimum follow-up of 8 years (R = 0.271).


Background and Rationale

For unstable elbow injuries involving a fracture of the radial head, restoration of radiocapitellar contact is important, with the choice between radial head fixation [11, 18, 26, 29, 30, 40, 45] and replacement [3, 6, 14, 20, 38]. Recent randomized trials and meta-analyses have suggested that replacement is superior to fixation [10, 15, 41, 44]. However, there are a limited number of studies regarding the long-term outcome of replacement to treat acute fractures of the radial head. Of the few studies reporting long-term outcomes [9, 21, 36, 42], most have small patient numbers; thus, definitive conclusions regarding implant durability and patient-reported outcomes over time are difficult to determine. Based on these deficiencies, we performed the current study to determine the survivorship after radial head replacement and the long-term patient-reported outcome of treatment, as well as to assess predictors of the long-term outcome.


This study has a number of limitations. First, our study is somewhat limited by the loss to follow-up. We were able to account for 80% of the living patients (80 of 100) at a minimum follow-up of 8 years, but 20% were lost and another 16% (19 of 119) of the potentially eligible died before we could contact them. In general, it is reasonable to assume that the health status of missing patients may be inferior to that of the accounted for, and so our survivorship rates and outcomes scores may represent best-case estimates. Because we did not examine patients in the outpatient clinic, we were unable to perform radiographs or functional testing to collect data on the development of elbow osteoarthritis, heterotopic ossification, and implant lysis. However, given the generally good patient-reported outcome scores among those who had not undergone revision or reoperation, we suggest that the functional and radiographic findings are unlikely to impact clinical decision-making. We advocate for implant removal in symptomatic patients, with stem lysis alone not an absolute indication as lysis with a deliberately loose implant is common. Although there was no difference in any patient-reported outcome at a minimum follow-up of 8 years for those undergoing prosthesis revision or removal, our statistical power on these endpoints was low, and revision surgery may well be associated with lower scores but the sample size here diminished our ability to detect it. Certainly, in other areas of reconstructive orthopaedic surgery (such as hip and knee replacement) revision surgery is associated with poorer outcomes scores than primary arthroplasty, and we would not be surprised if this were to be true here, as well.

Survivorship Analysis: Rate of Reoperation

We have reported a high rate of implant removal or revision after radial head replacement for these complex unstable injury patterns. However, restoration of radiocapitellar contact is essential in order to restore stability, with excision and ORIF not supported by the current data. All the cases in our series were all acute radial head replacements where fixation was not possible and there was associated elbow and/or forearm instability. A recent meta-analysis of radial head replacement reported that the pooled rate of revision or removal was 10% at a mean time of just over 3 years from surgery, with the highest incidence within 2 years after implantation [28]. Since publication of our study on short- to mid-term outcomes [17], only one additional patient has undergone removal at more than 10 years after the index procedure. This suggests that despite the high revision or removal rate we have reported here with a cumulative survival rate of 71%, our survivorship analysis demonstrates that this rate does not increase over time and these procedures tend to be performed relatively early, with 70% of all procedures in our series occurring within 1 year of implantation. It should also be noted that some of these implant removals were performed as part of an arthrolysis for postoperative stiffness. Flinkkila et al. [19] assessed the radiographs of 37 patients who underwent radial head replacement with metallic press-fit stems at a mean of 50 months (range 12 to 107 months). Nine implants (24%) were removed and three (8%) loosened, with a mean time to loosening of 11 months (range 2 to 24 months), which is consistent with our data and those of Laumonerie et al. [31]. In contrast, Sershon et al. [42] reported a 97% survivorship in 16 patients treated with a bipolar radial head replacement design and a mean DASH score of 8 (range 0 to 53) despite 14 patients (88%) demonstrating radiographic stem lysis at a mean long-term follow-up period of 11 years. This, combined with another study reporting 100% survivorship with 66% having evidence of radiographic lucency [8], suggests that signs of radiographic lucency do not appear to be associated with patient outcome.

Long-term Patient-reported Outcomes Scores After Treatment

Satisfactory longer-term patient reported outcome scores were reported despite the high number of patients requiring implant revision or removal in our series. Laumonerie et al. [31] recently published the mid-term results for 77 patients treated with one of four different types of radial head replacement implants (seven monopolar, 70 bipolar; all tight fitting) at a mean of 6 years and found a mean QuickDASH score of 14 and a Mayo Elbow Performance score of 90. Despite this, the authors concluded that the mid-term outcomes were unsatisfactory, primarily because the implant removal percentage was 25% and the overall reoperation percentage was 39%. The mean QuickDASH score and implant survival in that study were comparable to our data, suggesting that a good outcome can be maintained in the longer term. Additionally, and perhaps more importantly, the number of secondary interventions may not increase during the transition from mid- to long-term follow-up. Chen et al. [8] reported the long-term outcome in a smaller cohort of patients (n = 32; primary radial head replacement = 24; salvage radial head replacement = 8); the long-term mean QuickDASH score was 12 (range 0 to 50) and the Mayo Elbow Performance score was 83 (range 45 to 100) at a mean follow-up duration of 9 years. The patient outcome was better in patients treated with primary radial head replacement than in those undergoing a salvage or revision procedure. Implant radiolucency was seen in 66% (21) of patients, but there were no differences in outcome scores between patients with radiolucency and those without. Although Chen et al. [8] used a loose-fitting monopolar prosthesis and there was close agreement between their outcome scores and ours, the authors of this previous study did not report a single instance of implant revision or removal.

Factors Associated with Longer-term Outcome according to the QuickDASH

The findings of our study suggest there was no factor associated with the longer-term patient-reported outcome, but given the small sample size for both implant removal and design, no definitive conclusions can be made. Regarding implant design, a range of radial head replacements and implantation techniques is available, with contrasting short- to mid-term clinical results [1, 6, 9, 14, 17, 20, 28, 33, 37, 42, 43]. Analyses of mid-term follow-up have reported early prosthetic loosening, pain, and stiffness in patients who frequently undergo reintervention, principally with implant removal [17, 19, 28]. Despite variation in implant designs and implantation techniques, a recent systematic review found no strong evidence to support the use of a single prosthesis but suggested that silastic implants should be avoided [22]. Additionally, a meta-analysis suggested that rigid implant fixation could increase the risk of revision and complications [1]. This is consistent with our previous study that found that silastic implants were an independent predictor of revision or removal of the prosthesis [17]. Although the findings of this current study suggest that a silastic implant design has no impact on patient-reported outcomes at a minimum follow-up of 8 years, this finding is obviously limited by the very small number of patients who had silastic implants.


We have reported a high risk of implant removal or revision after radial head replacement for these complex unstable injury patterns. A low level of functional disability according to our primary outcome was reported despite this, although the study is under-powered to determine if implant removal negatively affects this score, as it does in many other areas of orthopaedic surgery. We feel that our indications for acute radial head replacement are consistent with the current evidence and would suggest restoration of radiocapitellar contact is essential for these unstable injury patterns, despite the high rate of subsequent implant removal. The findings of this study can be used to inform surgeons and patients regarding the longer-term prognosis after complex injuries that are managed with radial head replacement.


We thank the Scottish Orthopaedic Research Trust into Trauma for the assistance in performing this study, particular for data collection and follow-up. We thank Professor Charles Court-Brown MD, FRCSEd(Orth) and Mr. Nicholas Clement PhD, FRCSEd(Orth) for their contributions to data collection and statistical analysis.


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