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What Preoperative Factors are Associated With Not Achieving a Minimum Clinically Important Difference After THA? Findings from an International Multicenter Study

Rojanasopondist, Pakdee, BA; Galea, Vincent P., BA; Connelly, James W., BA; Matuszak, Sean J., BA; Rolfson, Ola, MD, PhD; Bragdon, Charles R., PhD; Malchau, Henrik, MD, PhD

Clinical Orthopaedics and Related Research®: June 2019 - Volume 477 - Issue 6 - p 1301–1312
doi: 10.1097/CORR.0000000000000667
SELECTED PROCEEDINGS FROM THE 7TH INTERNATIONAL CONGRESS OF ARTHROPLASTY REGISTRIES
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Background Despite innovations in THA, there remains a subgroup of patients who experience only modest pain relief and/or functional improvement after the procedure. Although several studies have previously sought to identify factors before surgery that were associated with achieving or not achieving a meaningful improvement after THA, there is no consensus on which factors are most associated; many studies have relied on single-center or single-country multicenter studies for their cohorts.

Questions/purposes We sought to identify (1) the proportion of patients who do not achieve a minimum clinically important difference (MCID) in pain and function 1 year after THA, and (2) the preoperative factors that were associated with not achieving MCIDs in pain and function 1 year after THA.

Methods This retrospective study analyzed data gathered from a prospective international, multicenter study examining the long-term clinical outcomes of two different polyethylene liners and two different acetabular shells. A total of 814 patients from 12 centers across four countries were enrolled in the study, with the final cohort consisting of 594 patients (73%) who all had complete preoperative and 1-year PROMs as well as a valid preoperative radiograph used to measure minimum joint space width. The outcomes in this study were achieving evidence-derived MCIDs in (1) pain, defined as a reduction of two points on an 11-point (0 = very little, 10 = worst imaginable) numerical rating scale (NRS) for hip-related pain or reporting a 1 year NRS-pain score of 0, and (2) function, defined as an increase equal to or greater than 8.3 on the SF-36 Physical Function subscore (range: 0 to 100; 0 = maximum disability, 100 = no disability) or reporting a 1-year SF-36 Physical Function subscore within the 95th percentile of scores in our cohort. All demographic variables, such as age, sex, country; surgical factors, including body mass index (BMI), surgical approach, acetabular liner type, and preoperative PROMs, were included as covariates in a binary logistic regression model. We used a backwards stepwise elimination algorithm to reach the simplest, best-fit model.

Results In the final analysis cohort of 594 patients, 54 patients (9%) did not achieve the MCID in pain and 146 (25%) patients did not achieve the MCID in physical function after THA. After controlling for potential confounding variables such as age, BMI, and preoperative PROMs, we found that higher joint space width (odds ratio (OR) = 2.19; 95% confidence interval (CI) = 1.49–3.22; p < 0.001), lower preoperative SF-36 Mental Component Summary (MCS) (OR = 0.95; 95% CI = 0.93–0.98; p = 0.001), and female sex (OR = 2.04; 95% CI = 1.08–3.82; p = 0.027) were associated with failing to achieve a MCID in pain. It is important to note that the effect size of having a higher preoperative SF-36 MCS is small, with a 1- or 10-point increase in SF-36 MCS decreasing the odds of a patient not achieving the pain MCID by 5% or 63%, respectively.

In a separate multivariable model, after controlling for potential confounding variables such as age, BMI, and preoperative PROMs, we found that higher joint space width (OR = 1.54; 95% CI = 1.18–2.02; p = 0.002), higher preoperative Harris hip score (HHS) (OR = 1.01; 95% CI = 1.00–1.03; p = 0.019) and undergoing surgery in Scandinavia (OR = 1.73; 95% CI = 1.17–2.55; p = 0.006) were associated with failing to achieve a MCID in physical function. It is important to note that the effect size of having a higher preoperative HHS is very small, with a 1- or t10-point increase in HHS increasing the odds of not achieving the physical function MCID by only 1% or 15%, respectively.

Conclusions These findings suggest that surgeons should counsel patients with high joint space width, female patients, and patients undergoing surgery in Scandinavia that they may be much less likely to experience meaningful pain relief or functional improvement after THA, and in light of that, determine whether indeed surgery should be postponed or avoided in those patients. Lower SF-36 MCS score and higher HHS before surgery were also found to be associated with not achieving MCIDs in pain and physical function, respectively, after surgery, but both had relatively small effect sizes. Future prospective studies may consider exploring the relationship between less pain relief or functional improvement and the risk factors identified in this study, such as high joint space width, to validate our findings and determine if the variables we identified are truly predictive of worse postoperative outcomes. Future retrospective studies of regional or national registry data should use the analysis methods presented within this study to both identify the portion of the THA patients who do not achieve a MCID in pain or physical function after surgery and confirm if the preoperative risk factors for poor improvement identified within our international, multicenter cohort are also found in a larger patient population with more diverse implants and comorbidities.

Level of Evidence Level III, therapeutic study.

P. Rojanasopondist, V. P. Galea , J. W. Connelly , S. J. Matuszak, C. R. Bragdon, H. Malchau, Harris Orthopaedics Laboratory, Massachusetts General Hospital, Boston, MA, USA

O. Rolfson, Department of Orthopaedics Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

P. Rojanasopondist, Harris Orthopaedics Laboratory, Massachusetts General Hospital, 55 Fruit St. GRJ 1231, Boston, MA 02114, USA, Email: projanasopondist@mgh.harvard.edu

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

The institution of one or more of the authors (PR, VPG, JWC, SJM, CRB, HM) has received, during the study period, research support funding in an amount of USD 100,001 to USD 1,000,000 from Zimmer Biomet.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

Investigation performed at Harris Orthopaedics Laboratory, Massachusetts General Hospital, Boston, MA, USA.

Received September 17, 2018

Accepted January 17, 2019

© 2019 Lippincott Williams & Wilkins LWW
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