Patient-reported Outcome Measures Scores Research Articles

Unicompartmental knee arthroplasty vs high tibial osteotomy for knee osteoarthritis: A comparison of clinical and radiological outcomes

BACKGROUND Unicompartmental knee arthroplasty (UKA) and high tibial osteotomy (HTO) are well-established operative interventions in the treatment of knee osteoarthritis. However, which intervention is more beneficial to patients with knee osteoarthritis remains unknown and a topic of much debate. Simultaneously, there is a paucity of research assessing the relationship between radiographic parameters of knee joint alignment and patient-reported clinical outcomes, preoperatively and following HTO or UKA. AIM To compare UKAs and HTOs as interventions for medial-compartment knee osteoarthritis: Examining differences in clinical outcome and investigating the relationship of joint alignment with respect to this. METHODS This longitudinal observational study assessed a total of 42 patients that had undergone UKA (n = 23) and HTO (n = 19) to treat medial compartment knee osteoarthritis. Patient-reported outcome measures (PROMs) were collected to evaluate clinical outcome. These included two disease-specific (Knee Injury and Osteoarthritis Outcome Score, Oxford Knee Score) and two generic (EQ-5D-5L, Short Form-12) PROMs. The radiographic parameters of knee alignment assessed were the: Hip-knee-ankle angle, mechanical axis deviation and angle of Mikulicz line. RESULTS Statistical analyses demonstrated significant (P < 0.001), preoperative to postoperative, improvements in the PROM scores of both groups. There were, however, no significant inter-group differences in the postoperative PROM scores of the UKA and HTO group. Several significant correlations associated a more distolaterally angled Mikulicz line with worse knee function and overall health preoperatively (P < 0.05). Postoperatively, two clusters of significant correlations were observed between the disease-specific PROM scores and knee joint alignment parameters (hip-knee-ankle angle, mechanical axis deviation) within the HTO group; yet no such associations were observed within the UKA group. CONCLUSION UKAs and HTOs are both efficacious operations that provide a comparable degree of clinical benefit to patients with medial compartment knee osteoarthritis. Clinical outcome has a limited association with radiographic parameters of knee joint alignment postoperatively; however, a more distolaterally angled Mikulicz line appears associated with worse knee function/health-related quality of life preoperatively.

Abstract PO4-11-12: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

Abstract Background: In pegulicianine fluorescence guided surgery (pFGS), a standard of care lumpectomy procedure is performed, and additional tissue is taken from cavity walls at sites of high pFGS signal. This approach been shown to reduce 2nd surgeries and remove additional tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS. Methods: A prospective Pivotal trial of pFGS in women undergoing lumpectomy surgery for stage 0-III breast cancer was conducted at 14 US sites (NCT03686215). We assessed the safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time. Patient Reported Outcome Measures (PROM) data was collected as an exploratory endpoint. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data. An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy. Descriptive statistics of participating patients’ responses were collected and analyzed. Survey results were analyzed by the distribution of patient ratings for each question and the change in the distribution of ratings over time, with comparison of baseline to post-lumpectomy. Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS. Results: Of the 357 patients evaluated for efficacy in the primary Pivotal study analysis, 255 patients agreed to participate in the PROM surveys (71%). Approximately 60% of the participating respondents completed a pre- and initial post-lumpectomy survey while only 34% of the participating patients completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p >0.05). There were 4 patients with scores of 3 or higher pre-surgery but 2 or lower post-surgery. Among these, 1 had no pFGS-guided shaves taken. The remaining 3 had had pFGS-guided shaves taken, but 2 required a second lumpectomy surgery and 1 underwent mastectomy, these additional surgeries likely accounting for decreased cosmetic outcomes. Discussion: Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries. This data was collected during the COVID-19 pandemic, which may have adversely impacted the compliance rate of survey completion. Studies in larger cohorts with longer follow up are required to better assess the relative impact of 2nd surgeries, radiation, and systemic therapy on breast satisfaction PROM scores after lumpectomy. Citation Format: Kelly Hunt, Irene Wapnir, E Shelley Hwang, David Carr, Peter Blumencranz, Kate Smith, Manna Chang, Jorge Ferrer, Barbara Smith. Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-12.

Survivorship and Patient Outcomes of Conforming Bearings in Modern Primary Total Knee Arthroplasty: Mean 3.5 Year Follow-Up

BackgroundConforming and congruent bearings in total knee arthroplasty (TKA) have rapidly increased due to the benefits of increased stability and the potential for replicating normal knee kinematics. However, limited data exist for these newly available bearings. This study evaluated revision-free survivorship and patient-reported outcome measures (PROMs) of a large granular database of primary TKAs using a single conforming bearing design. MethodsA total of 1,306 consecutive primary TKAs performed using a single conforming bearing design (85% cemented and 15% cementless) were retrospectively reviewed. Kaplan-Meier (KM) survivorship estimates were calculated based on the latest clinical follow-up. The PROMs and minimal clinically important differences (MCIDs) were evaluated. A total of 93% of cases achieved minimum 1-year clinical follow-up (mean 3.5 years; range, 1 to 7), with a subset of 261 cases that achieved minimum 5-year follow-up (mean 5.8 years; range, 5 to 7). ResultsAll-cause and aseptic KM survivorship estimates were 97.6 (95% CI [confidence interval], 97 to 99) and 98.1% (95% CI, 97 to 99) at 7.0 years. Revision-free survivorship did not differ by cemented or cementless fixation (98 versus 97%, P = 0.163). All PROM scores significantly improved from preoperative baseline (P < 0.001), and ≥ 86% of patients achieved MCIDs for Knee Society pain and Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) total scores. A total of 89% of cases reported their knees to ‘sometimes or always’ feel normal. For cases with minimum 5-year PROMs, 93% were ‘very satisfied’ or ‘satisfied.’ ConclusionConforming-bearing TKA demonstrated excellent survivorship up to 7.0 years. In addition, PROMs were comparable to other designs reported in the literature. While mid-term (mean 3.5-year) results are promising, long-term data are warranted on survivorship due to potential polyethylene wear in conforming bearings with more surface area in contact with articulating surfaces.

Impact of Preoperative Symptom Duration on Patient-Reported Outcomes Following Cervical Disc Replacement for Cervical Radiculopathy.

Retrospective review of prospectively collected data. To determine the impact of preoperative symptom duration on postoperative functional outcomes following cervical disc replacement (CDR) for radiculopathy. CDR has emerged as a reliable and efficacious treatment option for degenerative cervical spine pathologies. The relationship between preoperative symptom duration and outcomes following CDR is not well established. Patients with radiculopathy without myelopathy who underwent primary 1- or 2-level CDRs were included and divided into shorter (<6mo) and prolonged (≥6mo) cohorts based on preoperative symptom duration. Patient-reported outcome measures (PROMs) included Neck Disability Index (NDI), Visual Analog Scale (VAS) Neck and Arm. Change in PROM scores and minimal clinically important difference (MCID) rates were calculated. Analyses were conducted on the early (within 3mo) and late (6mo-2y) postoperative periods. A total of 201 patients (43.6±8.7y, 33.3% female) were included. In both early and late postoperative periods, the shorter preoperative symptom duration cohort experienced significantly greater change from preoperative PROM scores compared to the prolonged symptom duration cohort for NDI, VAS-Neck, and VAS-Arm. The shorter symptom duration cohort achieved MCID in the early postoperative period at a significantly higher rate for NDI (78.9% vs. 54.9%, P=0.001), VAS-Neck (87.0% vs. 56.0%, P<0.001), and VAS-Arm (90.5% vs. 70.7%, P=0.002). Prolonged preoperative symptom duration (≥6mo) was identified as an independent risk factor for failure to achieve MCID at the latest timepoint for NDI (OR: 2.9, 95% CI: 1.2-6.9, P=0.016), VAS-Neck (OR: 9.8, 95% CI: 3.7-26.0, P<0.001), and VAS-Arm (OR: 7.5, 95% CI: 2.5-22.5, P<0.001). Our study demonstrates improved patient-reported outcomes for those with shorter preoperative symptom duration undergoing CDR for radiculopathy, suggesting delayed surgical intervention may result in poorer outcomes and greater postoperative disability. III.

Impact of age on clinical outcomes in anterior cruciate ligament reconstruction.

Anterior cruciate ligament reconstruction (ACLR) is a common procedure for symptomatic ACL injuries. Age is often factored into clinical decision making and can influence the choice of conservative management over surgical intervention. The aim of this study was to investigate the effect of chronological age on the clinical outcome following ACLR. Six validated patient-reported outcome measures (PROM) were used to collect pre-operative and post-operative scores from patients with ACL rupture undergoing ACLR. Data were stratified pertaining to the patient's age at the time of surgery to compare the Younger Group (under 40years) with the Older Group (over 40years). A total of 45 patients were included in this study. Pre-operatively the Younger Group (n = 32) had significantly better Lysholm (p = 0.016), Tegner (p = 0.001), Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) sub-score (p = 0.003) and International Knee Documentation Committee (IKDC) score (p = 0.014) as compared to the Older Group (n = 13). Post-operatively, there was no significant difference (p > 0.05) between the two groups as all the PROM scores were comparable except for the Tegner score (p = 0.02), where younger patients had higher activity levels. Significant inverse correlations were only found between age and Tegner score (rho = - 0.58, p < 0.001) and KOOS Sport and Recreation sub-score (rho = - 0.33, p = 0.038). ACLR is a clinically successful treatment strategy for patients of all ages. Thus, age should not be used in isolation to determine patient suitability.

Evaluation of comorbidity scoring systems in patients undergoing knee arthroplasty.

Ageing populations are increasing the demand for knee arthroplasty. Concurrently, the prevalence of medical comorbidities are rising too. The Self-Administered Comorbidity Questionnaire was developed to provide a patient's assessment of their own comorbidities whereas the American Society of Anesthesiologists grades and the Charlson Comorbidity Index utilise clinical evaluation to objectively measure perioperative morbidity and mortality risk. The primary aim of this study was to compare Self-Administered Comorbidity Questionnaire scores with American Society of Anesthesiologists grades and Charlson Comorbidity Index scores. The secondary aim was to compare Self-Administered Comorbidity Questionnaire scores with knee outcome scores. A single centre observational cohort study of patients with knee osteoarthritis undergoing elective knee arthroplasty. Preoperative evaluation included Self-Administered Comorbidity Questionnaire scores, American Society of Anesthesiologists grades, Charlson Comorbidity Index scores and validated patient-reported outcome measures specific to knee surgery. A total of 141 patients were included in this study. Self-Administered Comorbidity Questionnaire scores were directly correlated with American Society of Anesthesiologists grade (rho = 0.37, p < 0.001) and Charlson Comorbidity Index scores (rho = 0.19, p = 0.047). Individual American Society of Anesthesiologists grades had significantly different Self-Administered Comorbidity Questionnaire scores (p = 0.001). Self-Administered Comorbidity Questionnaire scores were specifically associated with hypertension, ischaemic heart disease, chronic obstructive pulmonary disease and the total number of comorbidities, but American Society of Anesthesiologists and Charlson Comorbidity Index scores were associated with more comorbidities. Overall, Self-Administered Comorbidity Questionnaire scores were inversely correlated with patient-reported outcome measure scores. Self-Administered Comorbidity Questionnaire scores are associated with increasing comorbidity in patients with symptomatic knee osteoarthritis; however, American Society of Anesthesiologists grades and Charlson Comorbidity Index scores had stronger and more abundant associations with comorbidities and patient-reported outcome measure scores. Self-Administered Comorbidity Questionnaires may complement but not replace current objective assessments of comorbidity when evaluating perioperative risk for knee arthroplasty.

Comparison of Blood Flow Restriction Interventions to Standard Rehabilitation After an Anterior Cruciate Ligament Injury: A Systematic Review.

Blood flow restriction training (BFR-t) data are heterogeneous. It is unclear whether rehabilitation with BFR-t after an anterior cruciate ligament (ACL) injury is more effective in improving muscle strength and muscle size than standard rehabilitation. To review outcomes after an ACL injury and subsequent reconstruction in studies comparing rehabilitation with and without BFR-t. Systematic review. Level of evidence, 3. A search of English-language human clinical studies published in the past 20 years (2002-2022) was carried out in 5 health sciences databases, involving participants aged 18-65 undergoing rehabilitation for an ACL injury. Outcomes associated with muscle strength, muscle size, and knee-specific patient-reported outcome measures (PROMs) were extracted from studies meeting inclusion criteria and compared. The literature search identified 279 studies, of which 5 met the selection criteria. Two studies suggested that BFR-t rehabilitation after an ACL injury improved knee or thigh muscle strength and muscle size compared with rehabilitation consisting of comparable and higher load resistance training, with two studies suggesting the opposite. The single study measuring PROMs showed improvement compared to traditional rehabilitation, with no difference in muscle strength or size. BFR-t after an ACL injury seems to benefit muscle strength, muscle size, and PROM scores compared with standard rehabilitation alone. However, only 1 large study included all these outcomes, which has yet to be replicated in other settings. Further studies utilizing similar methods with a common set of outcome measures are required to confirm the effects of BFR-t on ACL rehabilitation.

Is Limited English Proficiency Associated With Differences in Care Processes and Treatment Outcomes in Patients Undergoing Orthopaedic Surgery? A Systematic Review

Background Approximately 25 million people in the United States have limited English proficiency. Current developments in orthopaedic surgery, such as the expansion of preoperative education classes or patient-reported outcome collection in response to bundled payment models, may exacerbate language-related barriers. Currently, there are mixed findings of the associations between limited English proficiency and care processes and outcomes, warranting a cross-study synthesis to identify patterns of associations. Questions/purposes In this systematic review, we asked: Is limited English proficiency associated with (1) differences in clinical care processes, (2) differences in care processes related to patient engagement, and (3) poorer treatment outcomes in patients undergoing orthopaedic surgery in English-speaking countries? Methods On June 9, 2023, a systematic search of four databases from inception through the search date (PubMed, Ovid Embase, Web of Science, and Scopus) was performed by a medical librarian. Potentially eligible articles were observational studies that examined the association between limited English proficiency and the prespecified categories of outcomes among pediatric and adult patients undergoing orthopaedic surgery or receiving care in an orthopaedic surgery setting. We identified 10,563 records, of which we screened 6966 titles and abstracts after removing duplicates. We reviewed 56 full-text articles and included 29 peer-reviewed studies (outcome categories: eight for clinical care processes, 10 for care processes related to patient engagement, and 15 for treatment outcomes), with a total of 362,746 patients or encounters. We extracted data elements including study characteristics, definition of language exposure, specific outcomes, and study results. The quality of each study was evaluated using adapted Newcastle-Ottawa scales for cohort or cross-sectional studies. Most studies had a low (48%) or moderate (45%) risk of bias, but two cross-sectional studies had a high risk of bias. To answer our questions, we synthesized associations and no-difference findings, further stratified by adjusted versus unadjusted estimates, for each category of outcomes. No meta-analysis was performed. Results There were mixed findings regarding whether limited English proficiency is associated with differences in clinical care processes, with the strongest adjusted associations between non-English versus English as the preferred language and delayed ACL reconstruction surgery and receipt of neuraxial versus general anesthesia for other non-Spanish versus English primary language in patients undergoing THA or TKA. Limited English proficiency was also associated with increased hospitalization costs for THA or TKA but not opioid prescribing in pediatric patients undergoing surgery for fractures. For care processes related to patient engagement, limited English proficiency was consistently associated with decreased patient portal use and decreased completion of patient-reported outcome measures per adjusted estimates. The exposure was also associated with decreased virtual visit completion for other non-Spanish versus English language and decreased postoperative opioid refill requests after TKA but not differences in attendance-related outcomes. For treatment outcomes, limited English proficiency was consistently associated with increased hospital length of stay and nonhome discharge per adjusted estimates, but not hospital returns. There were mixed findings regarding associations with increased complications and worse postoperative patient-reported outcome measure scores. Conclusion Findings specifically suggest the need to remove language-based barriers for patients to engage in care, including for patient portal use and patient-reported outcome measure completion, and to identify mechanisms and solutions for increased postoperative healthcare use. However, interpretations are limited by the heterogeneity of study parameters, including the language exposure. Future research should include more-precise and transparent definitions of limited English proficiency and contextual details on available language-based resources to support quantitative syntheses. Level of Evidence Level III, therapeutic study

Does lower dose pilocarpine have a role in radiation-induced xerostomia in the modern radiotherapy era? A single-center experience based on patient-reported outcome measures.

This study aims to investigate the efficacy of lower dose pilocarpine in alleviating late dry mouth symptoms in head and neck cancer patients received radiotherapy. Eighteen head and neck cancer patients experiencing persistent dry mouth were enrolled in this study. All participants started pilocarpine treatment a median of 6months post-radiotherapy. Initially, patients received pilocarpine at 5mg/day, with a gradual increase to the recommended dose of 15mg/day. A Patient-Reported Outcome Measurement (PROMs) questionnaire assessed symptoms' severity related to hyposalivation. All patients reported symptomatic dry mouth above grade 2 before starting the medication. Pilocarpine treatment continued based on patients' self-assessment, with a median duration of 12months (range, 3-36months). The median daily maintenance dose was 10mg (range, 5 to 20mg). Total PROMs scores significantly decreased following medication, from 13 points (range 7-18 points) to 7 points (range 4-13 points) (p = 0.001). Significant improvements were observed in questions related to dry mouth (p < 0.001), water intake during eating (p = 0.01), carrying water (p = 0.01), taste (p < 0.001), and water intake during speech (p < 0.001). Initial and maintenance doses of pilocarpine were lower, and the duration of pilocarpine usage was shorter in patients treated with intensity-modulated radiation therapy compared to conformal radiotherapy (12months vs. 25months, p = 0.04). Pilocarpine may be considered at doses lower for late-term dry mouth. With modern radiotherapy techniques effectively preserving the parotid gland, short-term use may be recommended in these patients. Future studies may enhance the development of a more robust patient selection criteria model.

Impact of Midfoot Charcot Arthropathy (Brodsky Type 1) on Patient Reported Outcome Scores

Introduction/Purpose: Charcot arthropathy is a debilitating and challenging clinical problem for patients and providers. Patient reported outcome measures (PROMs) are an effective tool for gauging a patient’s quality of life and daily functioning, but they have not been reported in the setting of Charcot arthropathy. Our goal is to assess PROMs severity in midfoot Charcot arthropathy (Brodsky Type 1), alongside linked demographics and comorbidities. We will compare these values with PROMs from conditions like ESRD, knee and hip arthritis, highlighting Charcot arthropathy's comparable debilitation. Methods: A retrospective chart review identified 67 patients with Brodsky Type 1 Charcot arthropathy by one of two fellowship- trained foot and ankle surgeons at a single academic medical center between years 2015 and 2023. ICD-10 CM codes E11.610, M14.671, and M14.672 were used to identify diagnosis of Charcot arthropathy and radiological interpretation determined Brodsky type. Data collected from patient charts included demographics, medical history, presence of ulcers, and preoperative Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12), Pain Catastrophizing Scale (PCS), Pain Disability Index (PDI), SSS- 8, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores and postoperative FAOS and FAAM scores. A One-Way ANOVA was performed to evaluate statistical significance. Averages of preoperative PROM scores were compared to literature values for other diseases. Results: Our cohort was mostly male (58.2%), with mean age 61.73 years, BMI 32.9, and A1C 6.9. Initial presentation revealed 50.7% had ulcers. Brodsky type 1 (midfoot) had notably the lowest pre-op PROM scores when compared to other Brodsky types: PDI Recreation (p=.033), FAOS Symptoms and Stiffness (p=.044), and FAOS Recreation (p=.027). Ulcer presence yielded significantly lower FAAM-ADL scores (p=.038), while other PROMs showed no statistical difference. Our mean VAS score was 53.34 which was higher than hip arthritis VAS (43.0) but lower than ESRD VAS (60.0) and knee arthritis VAS (64.2). Our SF-12 PCS scores (29.4) exceeded prior reports (hip 28.5, knee 28.6), while SF-12 MCS scores were higher in earlier studies (hip 49.6, knee 51.5) than our 43.8. Conclusion: Patients with Charcot arthropathy struggle in daily tasks, reflected in lowered FAOS ADL scores. Brodsky type 1 patients also face challenges in higher-level activities, evident in reduced PDI recreation and FAOS recreation scores. Those with ulcers similarly encounter issues in daily tasks, seen in lower FAAM ADL scores. Brodsky type 1 patients also experience debilitating pain as noted by higher VAS scores when compared to known debilitating conditions such as hip and knee arthritis. Comparatively minor differences in knee and hip arthritis SF-12 PCS scores indicate significant physical limitations for these patients.

Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study

BackgroundThe ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure.MethodsPre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models.ResultsData were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01–17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33–33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54–5.64), compared with those who did (reference).ConclusionSix-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.

Surgical Hip Dislocation in the Era of Hip Arthroscopy Demonstrates High Survivorship and Improvements in Patient-reported Outcomes for Complex Femoroacetabular Impingement.

Surgical Hip Dislocation in the Era of Hip Arthroscopy Demonstrates High Survivorship and Improvements in Patient-reported Outcomes for Complex Femoroacetabular Impingement.

Randomized controlled trials reporting patient-reported outcomes with no significant differences between study groups are potentially susceptible to unjustified conclusions—a systematic review

ObjectivesCeiling effect may lead to misleading conclusions when using patient-reported outcome measure (PROM) scores as an outcome. The aim of this study was to investigate the potential source of ceiling effect–related errors in randomized controlled trials (RCTs) reporting no differences in PROM scores between study groups. Study Design and SettingA systematic review of RCTs published in the top 10 orthopedic journals according to their impact factors was conducted, focusing on studies that reported no significant differences in outcomes between two study groups. All studies published during 2012–2022 that reported no differences in PROM outcomes and used parametric statistical approach were included. The aim was to investigate the potential source of ceiling effect–related errors—that is, when the ceiling effect suppresses the possible difference between the groups. The proportions of patients exceeding the PROM scales were simulated using the observed dispersion parameters based on the assumed normal distribution, and the differences in the proportions between the study groups were subsequently analyzed. ResultsAfter an initial screening of 2343 studies, 190 studies were included. The central 95% theoretical distribution of the scores exceeded the PROM scales in 140 (74%) of these studies. In 33 (17%) studies, the simulated patient proportions exceeding the scales indicated potential differences between the compared groups. ConclusionIt is common to have a mismatch between the chosen PROM instrument and the population being studied increasing the risk of an unjustified “no difference” conclusion due to a ceiling effect. Thus, a considerable ceiling effect should be considered a potential source of error.

Achieving satisfactory functional outcomes in conservatively treated proximal humerus fractures: relationship between shoulder range of motion and patient-reported clinical outcome scores

Proximal humerus fractures are common osteoporotic fractures. Postinjury outcome measures include objective clinician-measured range of motion (ROM) and subjective patient-reported outcome measures (PROMs), but the relationship between both has not been established. This study aimed to determine the relationship between shoulder ROM and PROMs and establish which ROMs correlated most with PROMs. A prospective cohort study was conducted on patients with acute proximal humerus fractures. Surgical intervention, open or pathological fractures, neurovascular compromise, polytrauma, or delayed presentations were excluded. Correlation and regression analyses between active ROM and PROMs (Quick Disabilities of Arm, Shoulder and Hand [QuickDASH] and Oxford Shoulder Score [OSS]) at 1-year postinjury were explored. ROM cutoffs predicting satisfactory PROM scores were established. Fifty-five patients were recruited. Moderate correlations were observed between PROMs and flexion, extension, and abduction, but not internal and external rotation. Multivariate analysis showed significant relationships between PROMs and flexion [QuickDASH: adjusted coefficient (AC):-0.135, P=.013, OSS: AC: 0.072, P=.002], abduction [QuickDASH: AC:-0.115, P=.021, OSS: AC: 0.059, P=.005], and extension [QuickDASH: AC:-0.304, P=.020] adjusting for age, gender, Neer classification, injury on dominant side, and employment. Achieving 130° flexion, 59° extension, and 124° abduction were correlated with satisfactory OSS/QuickDASH scores, respectively. Overall, holistic assessment of outcomes with both subjective and objective outcomes are necessary, as shoulder flexion, extension, and abduction are only moderately correlated with PROMs. Attaining 130° flexion, 59° extension, and 124° abduction corresponded with satisfactory functional outcomes measured by OSS/QuickDASH and can guide rehabilitation.

Who Benefits From Hip Arthroplasty or Knee Arthroplasty? Preoperative Patient-reported Outcome Thresholds Predict Meaningful Improvement.

Hip arthroplasty (HA) and knee arthroplasty (KA) are high-volume procedures. However, there is a debate about the quality of indication; that is, whether surgery is truly indicated in all patients. Patient-reported outcome measures (PROMs) may be used to determine preoperative thresholds to differentiate patients who will likely benefit from surgery from those who will not. (1) What were the minimum clinically important differences (MCIDs) for three commonly used PROMs in a large population of patients undergoing HA or KA treated in a general orthopaedic practice? (2) Do patients who reach the MCID differ in important ways from those who do not? (3) What preoperative PROM score thresholds best distinguish patients who achieve a meaningful improvement 12 months postsurgery from those who do not? (4) Do patients with preoperative PROM scores below thresholds still experience gains after surgery? Between October 1, 2019, and December 31, 2020, 4182 patients undergoing HA and 3645 patients undergoing KA agreed to be part of the PROMoting Quality study and were hence included by study nurses in one of nine participating German hospitals. From a selected group of 1843 patients with HA and 1546 with KA, we derived MCIDs using the anchor-based change difference method to determine meaningful improvements. Second, we estimated which preoperative PROM score thresholds best distinguish patients who achieve an MCID from those who do not, using the preoperative PROM scores that maximized the Youden index. PROMs were Hip Disability and Osteoarthritis Outcome Score-Physical Function short form (HOOS-PS) (scored 0 to 100 points; lower indicates better health), Knee Injury and Osteoarthritis Outcome Score-Physical Function short form (KOOS-PS) (scored 0 to 100 points; lower indicates better health), EuroQol 5-Dimension 5-level (EQ-5D-5L) (scored -0.661 to 1 points; higher indicates better health), and a 10-point VAS for pain (perceived pain in the joint under consideration for surgery within the past 7 days) (scored 0 to 10 points; lower indicates better health). The performance of derived thresholds is reported using the Youden index, sensitivity, specificity, F1 score, geometric mean as a measure of central tendency, and area under the receiver operating characteristic curve. MCIDs for the EQ-5D-5L were 0.2 for HA and 0.2 for KA, with a maximum of 1 point, where higher values represented better health-related quality of life. For the pain scale, they were -0.9 for HA and -0.7 for KA, of 10 points (maximum), where lower scores represent lower pain. For the HOOS-PS, the MCID was -10, and for the KOOS-PS it was -5 of 100 points, where lower scores represent better functioning. Patients who reached the MCID differed from patients who did not reach the MCID with respect to baseline PROM scores across the evaluated PROMs and for both HA and KA. Patients who reached an MCID versus those who did not also differed regarding other aspects including education and comorbidities, but this was not consistent across PROMs and arthroplasty type. Preoperative PROM score thresholds for HA were 0.7 for EQ-5D-5L (Youden index: 0.55), 42 for HOOS-PS (Youden index: 0.27), and 3.5 for the pain scale (Youden index: 0.47). For KA, the thresholds were 0.6 for EQ-5D-5L (Youden index: 0.57), 39 for KOOS-PS (Youden index: 0.25), and 6.5 for the pain scale (Youden index: 0.40). A higher Youden index for EQ-5D-5L than for the other PROMs indicates that the thresholds for EQ-5D-5L were better for distinguishing patients who reached a meaningful improvement from those who did not. Patients who did not reach the thresholds could still achieve MCIDs, especially for functionality and the pain scale. We found that patients who experienced meaningful improvements (MCIDs) mainly differed from those who did not regarding their preoperative PROM scores. We further identified that patients undergoing HA or KA with a score above 0.7 or 0.6, respectively, on the EQ-5D-5L, below 42 or 39 on the HOOS-PS or KOOS-PS, or below 3.5 or 6.5 on a 10-point joint-specific pain scale presurgery had no meaningful benefit from surgery. The thresholds can support clinical decision-making. For example, when thresholds indicate that a meaningful improvement is not likely to be achieved after surgery, other treatment options may be prioritized. Although the thresholds can be used as support, patient preferences and medical expertise must supplement the decision. Future studies might evaluate the utility of using these thresholds in practice, examine how different thresholds can be combined as a multidimensional decision tool, and derive presurgery thresholds based on additional PROMs used in practice. Preoperative PROM score thresholds in this study will support clinicians in decision-making through objective measures that can improve the quality of the recommendation for surgery.

10-Year Prospective Clinical and Radiological Evaluation After Matrix-Induced Autologous Chondrocyte Implantation and Comparison of Tibiofemoral and Patellofemoral Graft Outcomes

Background: Long-term outcomes in larger cohorts after matrix-induced autologous chondrocyte implantation (MACI) are required. Furthermore, little is known about the longer-term clinical and radiological outcomes of MACI performed in the tibiofemoral versus patellofemoral knee joint. Purpose: To present the 10-year clinical and radiological outcomes in patients after MACI and compare outcomes in patients undergoing tibiofemoral versus patellofemoral MACI. Study Design: Case series; Level of evidence, 4. Methods: Between September 2002 and December 2012, 204 patients who underwent MACI were prospectively registered into a research program and assessed preoperatively and at 2, 5, and 10 years postoperatively. Of these patients, 168 were available for clinical review at 10 years, with 151 (of a total of 182) grafts also assessed via magnetic resonance imaging (MRI). Patients were evaluated using the Knee injury and Osteoarthritis Outcome Score, a visual analog scale for pain frequency and severity, satisfaction, and peak isokinetic knee extensor and flexor strength. Limb symmetry indices (LSIs) were calculated for strength measures. Grafts were scored on MRI scans via the MOCART (magnetic resonance observation of cartilage repair tissue) system, with a focus on tissue infill and an overall MRI graft composite score. Results: All patient-reported outcome measures improved (P < .0001) up to 2 years after surgery. Apart from the significant increase (P = .004) in the peak isokinetic knee extensor LSI, no other patient-reported outcome measure or clinical score had changed significantly from 2 to 10 years. At the final follow-up, 92% of patients were satisfied with MACI to provide knee pain relief, with 76% satisfied with their ability to participate in sports. From 2 to 10 years, no significant change was seen for any MRI-based MOCART variable nor the overall MRI composite score. Of the 151 grafts reviewed via MRI at 10 years, 14 (9.3%) had failed, defined by graft delamination or no graft tissue on MRI scan. Furthermore, of the 36 patients (of the prospectively recruited 204) who were not available for longer-term review, 7 had already proceeded to total knee arthroplasty, and 1 patient had undergone secondary MACI at the same medial femoral condylar site because of an earlier graft failure. Therefore, 22 patients (10.8%) essentially had graft failure over the period. At the final follow-up, patients who underwent MACI in the tibiofemoral (vs patellofemoral) joint reported significantly better Knee injury and Osteoarthritis Outcome Score subscale scores for Quality of Life (P = .010) and Sport and Recreation (P < .001), as well as a greater knee extensor strength LSI (P = .002). Even though the tibiofemoral group demonstrated better 10-year MOCART scores for tissue infill (P = .027), there were no other MRI-based differences (P > .05). Conclusion: This study reports the long-term review of a prospective series of patients undergoing MACI, demonstrating good clinical scores, high levels of patient satisfaction, and acceptable graft survivorship at 10 years. Patients undergoing tibiofemoral (vs patellofemoral) MACI reported better long-term clinical outcomes, despite largely similar MRI-based outcomes.

Evaluation of the long-term patient-reported outcomes after hip arthroplasty or joint preserving with Sugioka femoral osteotomy in patients with femoral head osteonecrosis

PurposeThis study retrospectively evaluated long-term clinical outcomes and patient-reported outcome measures (PROMs) in patients with osteonecrosis of the femoral head (ONFH) who underwent transtrochanteric rotational osteotomy (TRO), curved varus osteotomy (CVO), and total hip arthroplasty (THA).MethodsWe retrospectively reviewed the 109 hips in 96 patients (46 men, 50 women) who underwent CVO, TRO, or THA for ONFH treatment. The mean follow-up period for the TRO, CVO, and THA groups was 14.8, 11.5, and 13.3 years, respectively.ResultsThe THA conversion rate of the TRO patients was significantly higher than that of the patients with CVO, and the final clinical scores in the patients with TRO did not improve compared with preoperative scores. Postoperative PROMs showed that the total and pain scores of the patients with THA were significantly higher than those of patients with TRO and CVO, while the PROM score did not change between patients with TRO and CVO. The analysis further showed that the preoperative type C2, stage 3A, or postoperative type C1 and C2 were significant predictors of decreased final PROM scores.ConclusionThis study found that CVO and THA are clinically effective treatments for ONFH, with significant improvements compared with preoperative scores. However, THA was associated with significantly higher PROMs and pain scores than those of CVO and TRO in long-term follow-up. Furthermore, our results suggest that postoperative PROMs depend mainly on the preoperative level of collapse and postoperative transposed intact ratio of the articular surface of the femoral head.

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty.

Advances in implant material and design have allowed for improvements in total knee arthroplasty (TKA) outcomes. A cruciate retaining (CR) TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament. Limited research exists that has examined clinical outcomes or patient reported outcome measures (PROMs) of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant. It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores. To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design. A retrospective, multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System (JOURNEY™ II CR; Smith and Nephew, Inc., Memphis, TN) at an urban, academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon. Patient demographics, surgical information, clinical outcomes, and PROMs data were collected via query of electronic medical records. The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) and Patient-Reported Outcomes Measurement Information System (PROMIS®) scores. The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests. Of the 255 patients, 65.5% were female, 43.8% were White, and patients had an average age of 60.6 years. Primary osteoarthritis (96.9%) was the most common primary diagnosis. The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home (92.5%). There were 18 emergency department (ED) visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%, including a 2.4% orthopedic-related ED visit rate and a 4.7% non-orthopedic-related ED visit rate. There were three (1.2%) hospital readmissions within 90 d postoperatively. With a mean time to latest follow-up of 3.3 years, four patients (1.6%) required revision, two for arthrofibrosis, one for aseptic femoral loosening, and one for peri-prosthetic joint infection. There were significant improvements in KOOS JR, PROMIS Pain Intensity, PROMIS Pain Interference, PROMIS Mobility, and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores. The evaluated implant is an effective, novel design offering excellent outcomes and low complication rates. At a mean follow up of 3.3 years, four patients required revisions, three aseptic and one septic, resulting in an overall implant survival rate of 98.4% and an aseptic survival rate of 98.8%. The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.

The Promising 2-Year Performance of the Patient-Reported Outcomes Measurement Information System in Primary Hip Arthroscopy for Femoroacetabular Impingement Syndrome

Background: Minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds have been previously defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 1-year follow-up in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome; however, the MCID and PASS thresholds are yet to be defined for the PROMIS at 2-year follow-up. Purpose: (1) To establish MCID and PASS thresholds for the PROMIS Pain Interference (PROMIS-PI) and PROMIS Physical Function (PROMIS-PF) at 2-year follow-up and (2) to correlate PROMIS scores with hip-specific patient-reported outcome measure (PROM) scores. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Patients undergoing primary hip arthroscopy for femoroacetabular impingement syndrome between August and November 2020 with preoperative and minimum 2-year postoperative data were identified. Collected scores included those for the PROMIS-PI, PROMIS-PF, Hip Outcome Score–Activities of Daily Living (HOS-ADL), Hip Outcome Score–Sports Subscale (HOS-SS), International Hip Outcome Tool–12 (iHOT-12), and visual analog scale (VAS) for pain. MCID thresholds were calculated using the distribution-based method and PASS thresholds using the anchor-based method. Pearson correlation coefficients were used to compare scores between PROMs. Results: A total of 65 patients met the criteria for inclusion (72.3% female; mean age, 36.9 ± 13.5 years; mean body mass index, 26.2 ± 6.0). The mean follow-up was 25.3 ± 3.3 months. Significant preoperative to postoperative improvements were observed for all PROMs (P < .001). MCID thresholds and achievement rates were as follows: HOS-ADL, 10.1 and 75%, respectively; HOS-SS, 13.8 and 79%, respectively; iHOT-12, 14.0 and 67%, respectively; VAS pain, –13.8 and 78%, respectively; PROMIS-PI, –4.7 and 65%, respectively; and PROMIS-PF, 5.8 and 60%, respectively. PASS thresholds and achievement rates were as follows: HOS-ADL, 78.7 and 67%, respectively; HOS-SS, 76.4 and 62%, respectively; iHOT-12, 67.4 and 60%, respectively; VAS pain, 25.5 and 61%, respectively; PROMIS-PI, 57.0 and 65%, respectively; and PROMIS-PF, 45.6 and 58%, respectively. PROMIS-PI scores correlated most strongly with HOS-ADL (r = −0.836), HOS-SS (r = −0.767), and iHOT-12 (r = −0.719) scores and exhibited at least moderate correlations (r≥−0.595) with the other PROM scores. PROMIS-PF demonstrated moderate correlations with all the other PROM scores (r≥−0.586). Strong correlations were seen between the hip-specific PROM scores (r≥−0.745). Conclusion: This study defined 2-year MCID and PASS thresholds for the PROMIS-PI and PROMIS-PF and demonstrated moderate to strong correlations between PROMIS scores and hip-specific PROM scores.

Establishing the Minimally Important Difference for the KOOS-Joint Replacement and PROMIS Global-10 in Patients After Total Knee Arthroplasty.

Despite the overall prevalence and success of total knee arthroplasty (TKA), a significant portion of patients are dissatisfied with their outcomes. To assess the responsiveness and determine the minimally important difference (MID) of 2 patient-reported outcome measures (PROMs)-the Knee injury and Osteoarthritis Outcome Score-Joint Replacement (KOOS-JR) and the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS 10)-in patients after TKA. Cohort study (diagnosis); Level of evidence, 3. Included were patients who underwent TKA from August 2015 through August 2019 and completed baseline and postoperative KOOS-JR and PROMIS 10 surveys. The PROMIS 10 consists of 2 domains: physical health and mental health. Estimates for the reliable change index (RCI) and MID, using anchor-based and distribution-based methods, were calculated for each PROM. Regression modeling was used to determine whether patient and clinical factors predicted MID thresholds or MID achievement. A total of 1315 patients were included. Distribution-based MIDs, calculated using various methods from baseline scores, ranged from 19.3 to 31 for the KOOS-JR, and the RCI was 4.38. Of these patients, 293 (22.3%) demonstrated small or moderate improvement, and this cohort was included in the calculation of anchor-based MIDs. The anchor-based MIDs were 16.9 and 24.3 at 3-month and 1-year follow-up, respectively, and 66% of patients achieved the MID at 12 months. Higher preoperative PROM score, male sex, non-White race, and current smoker status were predictive of failing to achieve the anchor-based MID for KOOS-JR at 1 year postoperatively (P < .05). Higher preoperative PROM score and any 90-day adverse event predicted lower thresholds of important change in anchor-based MIDs. Higher baseline PROM scores, younger age, male sex, non-White ethnicity, higher American Society of Anesthesiologists classification, preoperative narcotics use, not smoking, and longer hospital stay were all associated with lower odds of achieving the MID on the KOOS-JR or either of the PROMIS 10 subscales. The study results demonstrated relevant values for interpretation of the KOOS-JR and PROMIS 10. While patient demographics did not accurately predict which patients would achieve the MID, some potential factors predicting successful patient-reported outcomes after TKA were identified.