Patient Selection in Randomized Controlled Trials of Total Knee Arthroplasty: A Systematic Review Assessing Inclusion Criteria.

BACKGROUND: Patients undergo total knee arthroplasty (TKA) at widely disparate stages of osteoarthritis, raising the possibility of high heterogeneity among patients enrolled in TKA research studies. Obscuration of treatment effectiveness and other problems that may stem from cohort heterogeneity can be controlled in clinical studies by rigorously defining target patients. The purpose of this review was to determine the extent to which randomized controlled trials (RCTs) on TKA use osteoarthritis severity, as defined by radiographic grade or patient-reported outcome measures (PROMs), in their inclusion criteria, and to investigate potential impact on outcome. METHODS: A search of PubMed, Embase, Scopus, Web of Science, and Cochrane databases used a combination of terms involving TKA, PROMs, and radiographic scoring. A total of 1,227 studies were independently reviewed by 2 screeners for the above terms. RCTs with ≥100 patients (236) and with <100 patients (325) undergoing TKA were analyzed with regard to the specific inclusion criteria and recruitment process. RESULTS: Among the identified RCTs with ≥100 patients, 18 (<8%, with a total of 2,952 randomized patients) used specific radiographic scoring or PROM thresholds in their inclusion criteria. Eleven of the 18 studies used specific radiographic scoring, such as the Kellgren-Lawrence or Ahlbäck classifications. Three studies used preoperative PROM thresholds: Knee Society Knee Score of <60, Knee Society Function Score of <60, Oxford Knee Score of <20, and Hospital for Special Surgery Score of <60. Among studies with <100 patients, 48 (<15%) used specific inclusion criteria. CONCLUSIONS: The vast majority of RCTs (>85%) did not enroll patients based on disease severity, as measured by PROM score thresholds or radiographic classifications, in their inclusion criteria. The lack of consistent inclusion criteria likely results in heterogeneous cohorts, potentially undermining the validity of RCTs on TKA. LEVEL OF EVIDENCE: Prognostic Level I . See Instructions for Authors for a complete description of levels of evidence.

Defining a successful total knee arthroplasty: a systematic review of metrics of clinically important changes.

BACKGROUND: Despite the increasing use of patient-reported outcome measures (PROMs), the methodology used to evaluate clinically significant postoperative outcomes after total knee arthroplasty (TKA) is variable. The review aimed to survey studies with identified PROM-based metrics of clinical efficacy and the assessment procedures after TKA. METHODS: The MEDLINE database was queried from 2008-2020. Inclusion criteria were: full texts, English language, primary TKA with minimum one-year follow-up, use of metrics for assessing clinical outcomes with PROMs, and primary derivations of metrics. The following PROM-based metrics were identified: minimal clinically important difference (MCID), minimum detectable change (MDC), patient acceptable symptom state (PASS), and substantial clinical benefit (SCB). Study design, PROM value data, and methods of derivation for metrics were recorded. RESULTS: We identified 18 studies (including 46,173 patients) that met the inclusion criteria. Across these studies, 10 different PROMs were employed, and MCID was derived in 15 studies (83%). The MCID was calculated using anchor-based techniques in nine studies (50%) and distribution techniques in eight studies (44%). PASS values were presented in two studies (11%) and SCB in one study (6%) using an anchor-based method; MDC was derived in four studies (22%) using the distribution method. CONCLUSION: There is variability in the TKA literature with respect to the definition and derivation of measurements of clinically significant outcomes. Standardization of these values may have implications for optimal case selection and PROM-based quality measurement, ultimately improving patient satisfaction and outcomes.

Metrics of Clinically Important Changes in Total Hip Arthroplasty: A Systematic Review.

BACKGROUND: Although patient-reported outcome measures (PROMs) have become a regularly used metric, there is little consensus on the methodology used to determine clinically relevant postoperative outcomes. We systematically reviewed the literature for studies that have identified metrics of clinical efficacy after total hip arthroplasty (THA) including minimal clinically important difference (MCID), patient acceptable symptom state (PASS), minimal detectable change (MDC), and substantial clinical benefit (SCB). METHODS: A systematic review examining quantitative metrics for assessing clinical improvement with PROMs following THA was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the MEDLINE database from 2008 to 2020. Inclusion criteria included full texts, English language, primary THA with minimum 1-year follow-up, use of metrics for assessing clinical outcomes with PROMs, and primary derivations of those metrics. Sixteen studies (24,487 THA patients) met inclusion criteria and 11 different PROMs were reported. RESULTS: MCIDs were calculated using distribution methods in 7 studies (44%), anchor methods in 2 studies (13%), and both methods in 2 studies (13%). MDC was calculated in 2 studies, PASS was reported in 1 study using anchor-based method, and SCB was calculated in 1 study using anchor-based method. CONCLUSION: There is a lack of consistency in the literature regarding the use and interpretation of PROMs to assess patient satisfaction. MCID was the most frequently reported measure, while MDC, SCB, and PASS were used relatively infrequently. Method of derivation varied based on the PROM used; distribution method was more frequently used for MCID.

Patient Experiences and Clinical Outcomes in a Multidisciplinary Perioperative Transitional Pain Service.

Siloed pain management across the perioperative period increases the risk of chronic opioid use and impedes postoperative recovery. Transitional perioperative pain services (TPSs) are innovative care models that coordinate multidisciplinary perioperative pain management to mitigate risks of chronic postoperative pain and opioid use. The objective of this study was to examine patients' experiences with and quality of recovery after participation in a TPS. Qualitative interviews were conducted with 26 patients from The Johns Hopkins Personalized Pain Program (PPP) an average of 33 months after their first PPP visit. A qualitative content analysis of the interview data showed that participants (1) valued pain expectation setting, individualized care, a trusting patient-physician relationship, and shared decision-making; (2) perceived psychiatric treatment of co-occurring depression, anxiety, and maladaptive behaviors as critical to recovery; and (3) successfully sustained opioid tapers and experienced improved functioning after PPP discharge. Areas for improved patient-centered care included increased patient education, specifically about the program, continuity of care with pain specialists while tapering opioids, and addressing the health determinants that impede access to pain care. The positive patient experiences and sustained clinical benefits for high-risk complex surgical patient support further efforts to implement and adapt similar models of perioperative pain care.

Periprosthetic Femur Fractures After Total Hip Arthroplasty: Does the Mode of Failure Correlate With Classification?

BACKGROUND: Periprosthetic femur fracture is one of the most common indications for reoperation after total hip arthroplasty. Our objectives were to evaluate the incidence of reoperation after the surgical treatment of periprosthetic femur fractures and to compare the mechanisms of failure between fractures around a stable femoral component and those with an unstable femoral component. METHODS: We identified a consecutive series of 196 surgically treated periprosthetic fractures after total hip arthroplasty between 2008 and 2017. Mean age was 72 years (range, 29-96 years), and 108 (55%) were women. The femoral component was unstable in 127 cases (65%) and stable in the remaining 69 cases (35%). Mean follow-up was 2 years. RESULTS: The 2-year cumulative probability of any reoperation was 19%. The most common indication for reoperation among the cases with a stable femoral component was nonunion, and the most common indication for reoperation among the cases with an unstable femoral component was infection. Fractures that originated at the distal aspect of the femoral component were associated with a high risk of nonunion (6 of 28 cases, P < .01) and reoperation (9 of 28 cases, P = .03). CONCLUSION: Surgeons should take measures to mitigate the failure modes that are distinct based on fracture type. The high infection rate after surgical management of B2 fracture suggests that additional antiseptic precautions may be warranted. For B1 fractures, particularly those originating near the distal aspect of the femoral component, augmenting fixation with orthogonal plating, spanning the entire femur, or revising the stem in cases of poor proximal bone should be considered.