scholarly journals Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rachid Rassir ◽  
Inger N. Sierevelt ◽  
Marjolein Schager ◽  
Peter A. Nolte ◽  
Maarten V. Rademakers ◽  
...  

Abstract Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). Even though providing satisfactory results for the majority of patients, some studies report dissatisfaction after TKA to be as high as 20%. Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. Implant manufacturers keep improving upon their designs in an attempt to improve functional outcomes. One of these novel knee systems is the Attune. To our knowledge, there are no clinical follow-up studies reporting results of the uncemented version. The main objective of this multicentre prospective observational study is to evaluate revision rate, complications, radiographic outcomes (i.e. alignment and radiolucent lines) and patient reported outcomes of the uncemented Attune mobile bearing TKA. Secondary objectives are (1) to assess physical function, return to sport and return to work after TKA and (2) to evaluate the long-term effect of preoperative psychological factors on satisfaction after TKA. Methods All patients presenting in the participating centres with knee pathology warranting joint replacement therapy will be considered for inclusion, an absolute indication for cemented fixation is the only exclusion criterium. Evaluation of clinical and radiographic performance (e.g. radiolucent lines) is done at 6 weeks, 6 months, 1 year, 5 years and 10 years after surgery using validated patient reported outcome measures. Cumulative revision rates are calculated after 5 and 10 years using Kaplan–Meier methods. Physical function is assessed with performance based measurements before and 1 year after surgery. Return to sports is assessed using the Tegner and University of California Los Angeles (UCLA) activity rating scale before and 1 year after surgery. Return to work is evaluated by inviting patients of working age to complete a short questionnaire 1 year after surgery. Psychologic factors are assessed using questionnaires for pain catastrophising, pain self-efficacy and mental health before, 5 years and 10 years after surgery. Preoperative psychologic scores are correlated to functional outcomes. Discussion The current study aims to report the clinical performance of a novel implant and can help provide insight in factors that play a role in satisfaction after TKA. Trial registration ClinicalTrials.gov identifier: NCT04247672 (January 30, 2020)

Author(s):  
Patricia M. Lutz ◽  
Michael Merkle ◽  
Philipp W. Winkler ◽  
Stephanie Geyer ◽  
Elmar Herbst ◽  
...  

Abstract Purpose To compare post-operative physical activity and return to work after combined posterolateral corner (PLC) reconstruction (PLC-R) in anterior cruciate ligament (ACL)- or posterior cruciate ligament (PCL)-based injuries. Methods Patients aged > 18 years undergoing PLC-R using the Larson technique combined with either ACL or PCL reconstruction were included. Outcome was evaluated retrospectively after a minimum follow-up of 24 months using Tegner Activity Scale, Activity Rating Scale (ARS), Knee Injury and Osteoarthritis Outcome Score (KOOS), work intensity according to REFA classification, and a questionnaire about type of occupation and time to return to work. Results A total of 32 patients (11 ACL-based injuries and 21 PCL-based injuries) were included. Mean follow-up was 56 ± 26 months in the ACL-based injury group and 59 ± 24 months in the PCL-based injury group. All patients in the ACL-based injury group and 91% of patients in the PCL-based injury group returned to sports activities. Comparing pre- and post-operative values, a significant deterioration of the Tegner Activity Scale and ARS was observed in the PCL-based injury group, whereas no significant change was observed in the ACL-based injury group. KOOS subscales were generally higher in the ACL-based injury with significant differences in the subscale sports and recreational activities. Patients with ACL-based injuries returned to work significantly earlier compared to patients with PCL-based injuries (11 ± 4 weeks vs. 21 ± 10 weeks, p < 0.05). Conclusion High rates of return to sports and work can be expected after combined PLC-R in both ACL- and PCL-based injuries. However, deterioration of sports ability must be expected in PCL-based injuries. ACL-based injuries led to superior patient-reported outcomes and an earlier return to work, as compared to PCL-based injuries. Level of evidence Level IV.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Irene L Katzan ◽  
Dolora R Wisco ◽  
Brittany Lapin

Background: Self-efficacy is the belief that one is able to respond to demands of a stressful situation and it has both direct and indirect effects on health. The study objective is to investigate the amount of variance in patient-reported physical function (PF) that is explained by self-efficacy compared to clinician-reported disability and other patient-reported domains of health, and evaluate whether self-efficacy mediates the relationship between PF and other domains of health. Methods: Observational cohort study of 248 patients who were seen in a cerebrovascular clinic 3/18/20 - 7/7/20 and completed the following patient-reported outcome measures (PROMs) as part of the routine office visit: PROMIS PF, general self-efficacy, fatigue, and pain interference. Linear regression models were constructed to determine the amount of variance (adjusted R 2 ) in PROMIS PF score explained by the modified Rankin Scale (mRS) and additional PROM scores. The mRS and individual PROMs were added separately to a base model adjusted for demographic characteristics. Mediation analysis was conducted to determine the extent to which self-efficacy mediated the relationship between PF and other PROMs. Results: Mean age of study cohort was 61.5 (SD=13.5) years and 48.4% were female. The base model explained 4.5% of the variance of PF. Adding PROMIS fatigue resulted in the largest increase in the proportion of variance explained (adj R 2 = 47.7%), followed by PROMIS self-efficacy (40.7%), PROMIS pain interference (38.7%), and mRS (26.6%). Self-efficacy significantly mediated the relationship between fatigue and PF (standardized indirect effect: 0.11 (bias-corrected 95% CI: 0.05-0.18), 20.9% of total effect) and pain interference and PF (standardized indirect effect 0.10 (95% CI: 0.06-0.17), 27.1% of total effect). Conclusion: PROMIS self-efficacy explains more variance in stroke patients’ perceived physical function than their disability. This suggests that interventions to improve self-efficacy could have a significant effect on patient’s perceived health. Patients’ fatigue, despite being partially mediated by self-efficacy, was a large contributor to self-reported PF and should be included as part of an evaluation of patient’s physical health.


2019 ◽  
Vol 7 (7_suppl5) ◽  
pp. 2325967119S0027
Author(s):  
Brandon C. Cabarcas ◽  
Grant Hoerig Garcia ◽  
Joseph Liu ◽  
Gregory Louis Cvetanovich ◽  
Anirudh K. Gowd ◽  
...  

Objectives: Superior capsular reconstruction (SCR) is a relatively new procedure to address irreparable rotator cuff tears and rotator cuff arthropathy. Biomechanical studies have produced favorable results on cadaveric models, but few studies have evaluated clinical outcomes, and none have addressed return to sport (RTS). The purpose of this study was to evaluate rates of RTS and functional outcomes after SCR compared to a reverse total shoulder arthroplasty (rTSA) matched cohort. Methods: A prospectively collected registry was queried retrospectively for consecutive patients who underwent SCR from 2015 to 2016. Inclusion criteria were ≥2 tendon irreparable rotator cuff tear by arthroscopic evaluation and minimum one-year follow up. All eligible SCR patients were matched by gender, age, handedness, and follow up time to patients that underwent rTSA with a similar preoperative diagnosis. All surgeries were performed by a single surgeon at one institution with consistent operative techniques. Patients were evaluated with the ASES questionnaire, VAS Pain Scale, as well as VR/SF-12 and VR6D. Patients were also administered a detailed outcomes survey regarding surgical history and return to sport and work activities. Results: Overall 75.0% of 32 eligible patients were available at follow up. Average age at surgery and follow up did not significantly differ between cohorts (p>0.500 both). Postoperative outcome scores for ASES, VAS, VR/SF-12, and VR6D did not differ (p>0.310 for all) between cohorts. Overall RTS rate was 77.8% for SCR and 87.5% for rTSA (p > 0.610). Average months to return to sports was significantly greater after SCR (7.3 ± 3.0) compared to rTSA (3.5 ± 2.2; p = 0.032). Patients in both cohorts participated in golf, weight-lifting, gym activity, basketball and cycling postoperatively. Direct RTS for these sports are displayed in Fig. 1. Return to work rate was 71.4% (10/14) SCR and 50.0% (4/8) rTSA (p = 0.326) at average 2.7 ± 2.8 and 1.9 ± 1.9 months, respectively (p = 0.591). Stratified by duty status, rates of return to work were sedentary (100% both SCR and rTSA), light (100% both SCR and rTSA), moderate (0% SCR and 66.67% rTSA), and heavy (0% both SCR and rTSA). Overall, 85.71% SCR patients and 90.0% rTSA patients were satisfied or very satisfied with their general postoperative outcome. Conclusion: At short-term follow-up, SCR patients had RTS rates comparable to rTSA patients with irreparable rotator cuff tears. However, time to RTS was more prolonged after SCR. Outcome scores did not significantly differ between the two cohorts, suggesting that SCR may achieve postoperative function and pain reduction similar to rTSA at one year. Return to work was also similar, although rates were not as high as return to sport. When stratified by duty status, return to more intense physical work demands was not consistent in either cohort. Despite this, over 85% of SCR and rTSA patients were satisfied postoperatively. The findings of this study demonstrate that SCR patients have high RTS levels, as well as similar functional outcomes and satisfaction compared to rTSA for irreparable rotator cuff tears. Clinicians can utilize this information for preoperative counseling, particularly with younger more athletic patients, considering SCR or rTSA for an irreparable rotator cuff tear.


2017 ◽  
Vol 38 (5) ◽  
pp. 496-501 ◽  
Author(s):  
Daniel M. Dean ◽  
Bryant S. Ho ◽  
Albert Lin ◽  
Daniel Fuchs ◽  
George Ochenjele ◽  
...  

Background: Risk factors associated with short-term functional outcomes in patients with operative ankle fractures have been established. However, no previous studies have reported the association between these risk factors and functional outcomes outside of the first postoperative year. We identified predictors of functional and pain outcomes in patients with operative ankle fractures using the Patient Reported Outcomes Measurement System (PROMIS) physical function (PF) and pain interference (PI) measures. Methods: We retrospectively reviewed a multicenter cohort of patients ≥18 years old who underwent operative management of closed ankle fractures from 2001 to 2013 with a minimum of a 2-year follow-up. Patients with pilon variants, Maisonneuve fractures, Charcot arthropathy, prior ankle surgery, and chronic ankle fractures were excluded. Patients meeting inclusion criteria were contacted and evaluated using the PROMIS PF and PI computerized adaptive tests. Patient demographic and injury characteristics were obtained through a retrospective chart review. Univariate and multivariate regression models were developed to determine independent predictors of physical function and pain at follow-up. Included in this study were 142 patients (64 women, 78 men) with a mean age of 52.7 years (SD = 14.7) averaging 6.3 years of follow-up (range 2-14). Results: Patients had a mean PF of 51.9 (SD = 10.0) and a mean PI of 47.8 (SD = 8.45). Multivariate analysis demonstrated that independent predictors of decreased PF included higher age (B = 0.16, P = .03), higher American Society of Anesthesiologists (ASA) class (B = 10.3, P < .01), and higher body mass index (BMI; B = 0.44, P < .01). Predictors of increased PI included higher ASA class (B = 11.5, P < .01) and lower BMI (B = 0.41, P < .01). Conclusion: At follow-up, increased ASA class, increased BMI, and higher age at time of surgery were independently predictive of decreased physical function. Factors that were associated with increased pain at follow-up include lower BMI and higher ASA class. ASA class had the strongest effect on both physical function and pain. Level of Evidence: Level IV, case series.


Author(s):  
Darius Hunt ◽  
Tina Zhang ◽  
Scott Koenig ◽  
Ali Aneizi ◽  
Gregory Perraut ◽  
...  

AbstractThe purpose of this study was to evaluate Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) 2 years following knee surgery, and identify preoperative factors associated with postoperative PROMIS PF. Three hundred and sixty-five patients, age 17 years and older, undergoing knee surgery at one institution were studied. Patients completed multiple questionnaires prior to surgery and again 2 years postoperatively including PROMIS PF, International Knee Documentation Committee (IKDC), joint and body numeric pain scales (NPS), Tegner's activity scale (TAS), and Marx's activity rating scale (MARS). Mean PROMIS PF improved from 41.4 to 50.9 at 2 years postoperatively (p < 0.001) and was strongly correlated with 2-year IKDC scores. Older age, female gender, non-Hispanic ethnicity, unemployment, lower income, government insurance, smoking, preoperative opioid use, having a legal claim, comorbidities, previous surgeries, higher body mass index (BMI), and knee arthroplasty were associated with worse 2-year PROMIS PF. Multivariable analysis confirmed that lower BMI, less NPS body pain, and higher MARS were independent predictors of greater 2-year PROMIS PF and better improvement in PROMIS PF. In this large, broad cohort of knee surgery patients, multiple preoperative factors were associated with PROMIS PF 2 years postoperatively. PROMIS PF scores improved significantly, but worse 2 year PROMIS PF scores and less improvement from baseline were independently predicted by higher BMI, greater NPS body pain, and lower MARS activity level. PROMIS PF can be implemented as an efficient means to assess outcomes after knee surgery.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18236-e18236
Author(s):  
William D. Tap ◽  
Rebecca M Speck ◽  
Xin Ye ◽  
Emanuela Palmerini ◽  
Silvia Stacchiotti ◽  
...  

e18236 Background: The double-blind, randomized, placebo-controlled phase 3 ENLIVEN study in TGCT demonstrated a significant tumor response at week 25 by RECIST for pexidartinib (39% vs. 0% for placebo) and improvement in joint function and symptoms. The aim of this analysis was to identify a threshold score for responder definitions for PROMIS-PF scale and Worst Stiffness Numerical Rating Scale (WS-NRS) and compared responder rates for pexidartinib versus placebo. Methods: Anchor- and distribution-based estimates were calculated, and cumulative distribution function (CDF) plots were generated to derive responder definition threshold estimates. Anchor- and distribution-based results and CDFs were evaluated through triangulation, following FDA PRO Guidance, to determine a single responder definition threshold (i.e., meaningful change) for each instrument. The proportion of responders at Week 25 between treatments was compared with Fisher’s Exact Test (2-sided). Results: 120 patients were randomized to pexidartinib (n = 61) and placebo (n = 59) and assessed through 25 weeks of treatment. Anchor-based analysis showed one-level improvement on the patient global rating of PF item was associated with a mean change of 4.0 on PROMIS-PF. Distribution-based estimates (0.5 SD and 1 SEM) for PROMIS-PF were 2.8 and 2.5, respectively. For WS-NRS, a response of “A little improved” by patients on the perception of stiffness item was associated with a mean change of 1.1. The distribution-based estimates for the WS-NRS item were 0.9 and 0.5, respectively. This resulted in the following responder definition thresholds: ≥3 points for PROMIS-PF and ≥1 for WS-NRS improvement. A greater proportion of pexidartinib as compared to placebo patients were responders by PROMIS-PF (30% vs. 5%, p < 0.001) and WS-NRS (39% vs. 19%, p = 0.02) at week 25, respectively. Conclusions: Triangulation yielded responder definitions of ≥3 points for PROMIS-PF and ≥1 for WS-NRS. With these definitions, a greater proportion of patients treated with pexidartinib compared to placebo had meaningful improvement in physical function and stiffness.


2021 ◽  
Vol 2 (12) ◽  
pp. 1089-1095
Author(s):  
Weisang Luo ◽  
Mohammed S. Ali ◽  
Richard Limb ◽  
Christine Cornforth ◽  
Daniel C. Perry

Aims The Patient-Reported Outcomes Measurement Information System (PROMIS) has demonstrated faster administration, lower burden of data capture and reduced floor and ceiling effects compared to traditional Patient Reported Outcomes Measurements (PROMs). We investigated the suitability of PROMIS Mobility score in assessing physical function in the sequelae of childhood hip disease. Methods In all, 266 adolscents (aged ≥ 12 years) and adults were identified with a prior diagnosis of childhood hip disease (either Perthes’ disease (n = 232 (87.2%)) or Slipped Capital Femoral Epiphysis (n = 34 (12.8%)) with a mean age of 27.73 years (SD 12.24). Participants completed the PROMIS Mobility Computer Adaptive Test, the Non-Arthritic Hip Score (NAHS), EuroQol five-dimension five-level questionnaire, and the Numeric Pain Rating Scale. We investigated the correlation between the PROMIS Mobility and other tools to assess use in this population and any clustering of outcome scores. Results There was a strong correlation between the PROMIS Mobility and other established PROMs; NAHS ( rs = 0.79; p < 0.001). There was notable clustering in PROMIS at the upper end of the distribution score (42.5%), with less seen in the NAHS (20.3%). However, the clustering was broadly similar between PROMIS Mobility and the comparable domains of the NAHS; function (53.6%), and activity (35.0%). Conclusion PROMIS Mobility strongly correlated with other tools demonstrating convergent construct validity. There was clustering of physical function scores at the upper end of the distributions, which may reflect truncation of the data caused by participants having excellent outcomes. There were elements of disease not captured within PROMIS Mobility alone, and difficulties in differentiating those with the highest levels of function. Cite this article: Bone Jt Open 2021;2(12):1089–1095.


Author(s):  
John Hee-Young Lee ◽  
James L. Cook ◽  
Nichole Wilson ◽  
Kylee Rucinski ◽  
James P. Stannard

AbstractClinical outcomes after reconstruction for multiligamentous knee injury (MLKI) can be consistently favorable. However, recent implants and technique advances may allow for improvement in outcomes. Our institution has developed novel graft constructs and techniques for reconstructions with preclinical data supporting clinical use. Our study purpose was to assess clinical outcomes after reconstruction for MKLI using our constructs and techniques. Overall success rate, failure/revision rates, return to work (RTW)/return to sports (RTS) rates, and complications were evaluated testing the hypothesis that novel methods would be associated with clinical benefits with respect to applications and outcomes compared with historical results. We reviewed a single-surgeon, longitudinal database of 42 patients who underwent multiligament reconstruction at our institution using these techniques for at least two-ligament injuries. Visual analogue scale (VAS) pain score and PROMIS (patient-reported outcomes measurement information system) were collected preoperatively and postoperatively at a minimum 1-year follow-up. Among these patients, 33 patients (mean age of 28.9 years, mean body mass index (BMI) of 33.2 kg/m2, mean follow-up of 14.2 months) were included for outcomes analyses. With the definition of success as having a VAS score of less than or equal to 2 without revision/salvage surgery due to recurrent/residual instability or arthritis, overall success rate was 88% (29/33). The mean VAS scores improved from 5 ± 2 to 2 ± 2. The mean preoperative PROMIS mental health score was 36.2 ± 7, general health was 33.5 ± 6, pain was 62.7 ± 8, and physical function score was 29.4 ± 3. At the final follow-up, PROMIS MH was 50.2 ± 10, GH was 44.4 ± 9, pain was 54.3 ± 9, and PF was 42.6 ± 8.4. Return to work rate was 94% (31/33), and 52% (17/33) of patients were able to RTS at any level. Our results demonstrated excellent clinical outcomes associated with a primary success rate of 88% and RTW rate of 94%. Intraoperative complications occurred in 9.5% of cases and revision and failure rates were 9% and 3%, respectively. Our initial results suggest that multiligament reconstructions using novel graft constructs and techniques are safe and effective and can be considered an appropriate option for reconstruction of the full clinical spectrum of MLKIs.


2021 ◽  
Author(s):  
Feng Liu ◽  
Zhen-xiang Zhang ◽  
Bei-lei Lin ◽  
Zhi-guang Ping ◽  
Yong-xia Mei

Abstract Background Self-efficacy is a significant predictor of return to work and affects the confidence of survivors to return to work after illness. The Return-to-work self-efficacy (RTW-SE) questionnaire is a self-report questionnaire to assess confidence in returning to work with good reliability and validity. The aim of this study was to translate and cross-culturally adapt the RTW-SE questionnaire into Chinese and examine the psychometric properties among young and middle-aged stroke survivors using rasch model analysis.Methods The cross-cultural adaptation and translation procedures followed a dual-translation approach. The psychometric properties of the RTW-SE questionnaire were examined using Rasch model analysis by Winsteps software. The unidimensionality and local independence were analyzed by principal component analysis and standardized residual correlations. Category diagnostics were performed for scale function, and the item fit, reliability, and separation were also validated. Item-person maps were used to examine the distribution and matching of item’s difficulty and person ability. Finally, the differential item functioning (DIF) was used to measure gender-related group equivalence.Results A total of 366 participants aged 23–59 years were recruited from three communities in Zhengzhou. The RTW-SE questionnaire demonstrated unidimensionality and a 5-point Likert rating scale was more appropriate to investigate young and middle-aged stroke survivors’self-efficacy. There was a good fit for the items with both person and item reliabilities greater than 0.8 and separation indices of 3.75 and 3.94, respectively. The item difficulty was identified from the item-person map as not covering person ability, but the scale did not have an age-related DIF.Conclusions The results confirm evidence of appropriate psychometric properties of the RTW-SE questionnaire and can be used as a reliable and validated instrument for measuring self-efficacy to return to work in young and middle-aged Chinese patients with stroke.


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