Three-and-a-half to 18 year outcome data for costal osteochondral grafts for salvage of the proximal pole of the scaphoid

Twelve patients who had undergone costal osteochondral graft reconstruction of the proximal pole of scaphoid were evaluated with clinical examination, patient-reported outcome scores and radiographs with an average follow-up of 10 years (range 3.5–18). The range of wrist motion was not significantly changed compared with the preoperative range of motion and functional outcomes scores were acceptable. The patients reported low pain scores despite the universal presence of radiographic changes of reduced carpal height and arthritis of the midcarpal and radiocarpal joints. Costal osteochondral graft reconstruction of the proximal pole of scaphoid offers good long-term pain relief and function. Level of evidence: IV

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Long-term Effects of Cheilectomy, Keller’s Arthroplasty, and Arthrodesis for Symptomatic Hallux Rigidus on Patient-Reported and Radiologic Outcome

Foot & Ankle International ◽

10.1177/1071100720919681 ◽

2020 ◽

Vol 41 (7) ◽

pp. 775-783

Author(s):

Jasper Stevens ◽

Robin T.A.L. de Bot ◽

Adhiambo M. Witlox ◽

Rob Borghans ◽

Thijs Smeets ◽

...

Keyword(s):

Pain Score ◽

Patient Reported Outcome ◽

Hallux Rigidus ◽

Original Study ◽

Level Of Evidence ◽

First Metatarsophalangeal Joint ◽

Pain Scores ◽

Patient Reported

Background: Several operative interventions are available to alleviate pain in hallux rigidus, and the optimal operative technique is still a topic of debate among surgeons. Three of these are arthrodesis, cheilectomy, and Keller’s arthroplasty. Currently, it is unclear which intervention yields the best long-term result. The aim of this study was to assess which of these interventions performed best in terms of patient-reported outcome, pain scores, and disease recurrence at long-term follow-up. Methods: These data are the follow-up to the initial study published in 2006. In the original study, 73 patients (n = 89 toes) with symptomatic hallux rigidus were recruited and underwent first metatarsophalangeal joint arthrodesis (n = 33 toes), cheilectomy (n = 28 toes), or Keller’s arthroplasty (n = 28 toes). Outcome measures were AOFAS hallux metatarsophalangeal-interphalangeal (HMI) score, and pain was assessed with a visual analog scale (VAS) at a mean follow-up period of 7 years. Patients of the original study were identified and invited to participate in the current study. Data were collected in the form of AOFAS-HMI score, VAS pain score, Manchester-Oxford Foot Questionnaire (MOXFQ), and Forgotten Joint Score (FJS-12). In addition, a clinical examination was performed and radiographs were obtained. Data were available for 37 patients (45 toes), with a mean follow-up period over 22 years. Results: AOFAS-HMI and VAS pain score improved during follow-up only in arthrodesis patients. Furthermore, no statistically significant differences in clinical and patient-reported outcome were detected between groups based on AOFAS-HMI, VAS pain, MOXFQ, or FJS-12. However, clinically important differences in patient-reported outcomes and pain scores were detected, favoring arthrodesis. Radiographic disease progression was more evident after cheilectomy compared with Keller’s arthroplasty. Conclusion: Arthrodesis, cheilectomy, and Keller’s arthroplasty are 3 sucessful operative interventions to treat symptomatic hallux rigidus. Because clinically important differences were detected and symptoms still diminish many years after surgery, a slight preference was evident for arthrodesis. Level of Evidence: Level III, comparative study.

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Comparison of Visual Analog Pain Score Reported to Physician vs Nurse

Foot & Ankle International ◽

10.1177/1071100717740584 ◽

2017 ◽

Vol 39 (3) ◽

pp. 300-303 ◽

Cited By ~ 6

Author(s):

Kevin D. Martin ◽

J. Preston Van Buren ◽

Jeffrey Wake ◽

Laura Dawson

Keyword(s):

Pain Score ◽

Nursing Staff ◽

Standard Of Care ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Pain Patient ◽

Level Of Evidence ◽

Pain Scores ◽

Patient Reported ◽

Vas Scores

Background: The visual analog scale (VAS) is considered a reliable and validated measure of patient-reported acute pain. Patient-reported outcome measures are becoming the standard of care throughout the orthopedic community, but interpretation and clinical applications are still under investigation. The aim of the current study was to compare preoperative patient-reported VAS scores reported at the same visit to nursing staff and the treating surgeon. Our hypothesis was that there would be no difference in the scores reported. Methods: This study is a retrospective cohort of 201 consecutive foot and ankle patients treated by a single surgeon. The patients were asked to rate their pain intensity by the nursing staff and then by the surgeon using a standard horizontal VAS 0 to 10, from “no pain” to the “worst pain.” Differences in reported pain values were analyzed. Results: The results demonstrate that patients reported higher pain scores to the surgeon in 81% of the encounters, nursing staff 8%, and equal 11%. On average, the VAS score reported to the surgeon was significantly ( P < .05) higher than that reported to the nursing staff. Conclusion: The current study found a statistically significant higher patient-reported pain score to the treating surgeon compared to the nursing staff. While the exact cause is unclear, the discrepant pain scores call into question the validity of the VAS, considered a fifth vital sign and standard outcome measure in an outpatient clinic setting. Level of Evidence: Level III, comparative study.

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Costo-osteochondral graft (rib graft) reconstruction of the irreparable proximal scaphoid

Journal of Hand Surgery (European Volume) ◽

10.1177/1753193420922786 ◽

2020 ◽

Vol 45 (7) ◽

pp. 693-699

Author(s):

Nadja A. Zechmann-Mueller ◽

Shirley Collocott ◽

Wolfgang Heiss-Dunlop

Keyword(s):

Donor Site ◽

Difficult Problem ◽

Osteochondral Graft ◽

Proximal Pole ◽

Level Of Evidence ◽

No Donor ◽

Angle Measurements ◽

Graft Reconstruction ◽

Objective Outcome

We present our series of 21 cases in which proximal scaphoid nonunions with fragmentation were treated with costo-osteochondral graft reconstruction (rib graft). The median follow-up was 29 months. Union was achieved in all 21 patients. There were significant improvements in subjective and objective outcome measurements and carpal alignment was well maintained in all patients, as shown by normal postoperative capitolunate angle measurements. No donor site complications were encountered. Rib graft reconstruction offers a reliable and straightforward option for the difficult problem of the irreparable proximal pole of the scaphoid. Level of evidence: IV

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Femoral Head Allografts for Talar Body Defects

Foot & Ankle International ◽

10.1177/1071100720983811 ◽

2021 ◽

pp. 107110072098381

Author(s):

J. Chris Coetzee ◽

Bryan D. Den Hartog ◽

Rebecca Stone McGaver ◽

Kayla J. Seiffert ◽

M. Russell Giveans

Keyword(s):

Femoral Head ◽

Case Series ◽

Ankle Arthrodesis ◽

Patient Reported Outcome ◽

Level Of Evidence ◽

Ankle Arthroplasty ◽

Pain Scores ◽

Patient Reported ◽

P 752 ◽

Ability Measure

Background: Large structural bone deficits after a failed ankle arthroplasty or avascular necrosis (AVN) of the talus present a complex reconstruction challenge. The aim of this study was to report the results of patients undergoing an ankle arthrodesis or tibiotalocalcaneal fusion using a femoral head allograft (FHA). Methods: All ankle and tibiotalocalcaneal fusions using FHA between February 2006 and January 2019 were included. Forty-four patients (45 ankles) with a mean follow-up of 42.8 months were studied. Males accounted for 58.1% (25/43 patients). All patients had either failure of primary or revision total ankle arthroplasty (TAA) or AVN of the talus. Pre- and postoperative Veterans RAND Health Survey (VR-12), Foot and Ankle Ability Measure (FAAM), Ankle Osteoarthritis Scale (AOS) and visual analog scale (VAS) for pain scores were obtained. A patient satisfaction survey was distributed postoperatively and results were tabulated. Results: Preoperatively to postoperatively, the VR-12 Mental score remained essentially unchanged ( P = .752) and the VR-12 Physical score improved ( P = .007); the FAAM Activities of Daily Living (ADL) and Sport scores improved ( P < .001); the AOS Pain and Disability scores improved ( P < .001); and the man VAS score improved ( P < .001). The overall satisfaction rate was 78.6 on a 100-point scale. At an average of 18.7 weeks, 90.7% of the ankles were substantially fused. Five patients went on to nonunions and revision surgery. Conclusion: The use of FHA to treat talar defects was a viable option. In this complex patient population, the arthrodesis rate was high at 89% with very positive patient-reported outcome scores. Level of Evidence: Level IV, case series.

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PatientConcept App � an innovative tool to improve therapy adherence and to implement risk management plans. (Preprint)

10.2196/preprints.11650 ◽

2018 ◽

Author(s):

Michael Lang ◽

Martin Mayr ◽

Stefan Ringbauer ◽

Lukas Cepek

Keyword(s):

Risk Management ◽

Disease Management ◽

Chronically Ill ◽

Patient Reported Outcome ◽

Outcome Data ◽

Daily Routine ◽

Software Application ◽

Patient Reported ◽

Management Plans ◽

Chronically Ill Patients

UNSTRUCTURED Background: Adherence constitutes a great challenge for disease management, particularly when treating chronically ill patients facing an extensive, complex and long-term therapy. Earlier studies emphasize the relevance of adherence for improving therapy benefits. Besides the positive impact of increased patient support, the use of mobile health applications has gained importance in disease management. Objective: We aimed to develop a software application providing innovative features to simplify the contact between patients and treating physicians in order to overcome adherence barriers, to implement risk management plans and to collect patient reported outcome data. Methods: A novel software application ensuring data security was developed. Various innovative modules have been implemented, enabling bidirectional communication between treating physicians and patients, supporting therapy monitoring and management and allowing the collection of large sets of anonymous patient data. Results: The PatientConcept app is freely available for download and is tested since 2016, with more than 1800 generated patient IDs and 279 patients documenting health data according to risk management plans online in 2017. The impact on adherence issues is currently tested in larger patient populations. Conclusion: This innovative app provides a feasible and cost-optimized possibility to intensify and simplify the communication between patients and their treating physicians across indications, thus promising an exceptional benefit to both. It may not only support chronically ill patients in managing their daily life and improving adherence, but can also facilitate the implementation of risk management plans through automated monitoring, thus supporting physicians in their daily routine. Furthermore, patient reported outcome data can be collected. Importantly, a secure ID-associated data management ensures patient anonymity complying with highest data safety standards.

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Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

Health and Quality of Life Outcomes ◽

10.1186/s12955-021-01800-1 ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Theresa M. Coles ◽

Adrian F. Hernandez ◽

Bryce B. Reeve ◽

Karon Cook ◽

Michael C. Edwards ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Contextual Factors ◽

The United States ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Think Tank ◽

Level Of Evidence ◽

Patient Reported ◽

Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

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Return to Sport After Large Single-Surface, Multisurface, or Bipolar Osteochondral Allograft Transplantation in the Knee Using Shell Grafts

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120967928 ◽

2021 ◽

Vol 9 (1) ◽

pp. 232596712096792

Author(s):

James L. Cook ◽

Kylee Rucinski ◽

Cory R. Crecelius ◽

Richard Ma ◽

James P. Stannard

Keyword(s):

Femoral Condyle ◽

Case Series ◽

Return To Sport ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Osteochondral Allograft ◽

Level Of Evidence ◽

Recreational Athletes ◽

Patient Reported

Background: Return to sport (RTS) after osteochondral allograft (OCA) transplantation for large unipolar femoral condyle defects has been consistent, but many athletes are affected by more severe lesions. Purpose: To examine outcomes for athletes who have undergone large single-surface, multisurface, or bipolar shell OCA transplantation in the knee. Study Design: Case series; Level of evidence, 4. Methods: Data from a prospective OCA transplantation registry were assessed for athletes who underwent knee transplantation for the first time (primary transplant) between June 2015 and March 2018 for injury or overuse-related articular defects. Inclusion criteria were preinjury Tegner level ≥5 and documented type and level of sport (or elite unit active military duty); in addition, patients were required to have a minimum of 1-year follow-up outcomes, including RTS data. Patient characteristics, surgery type, Tegner level, RTS, patient-reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures were assessed and compared for statistically significant differences. Results: There were 37 included athletes (mean age, 34 years; range, 15-69 years; mean body mass index, 26.2 kg/m2; range, 18-35 kg/m2) who underwent large single-surface (n = 17), multisurface (n = 4), or bipolar (n = 16) OCA transplantation. The highest preinjury median Tegner level was 9 (mean, 7.9 ± 1.7; range, 5-10). At the final follow-up, 25 patients (68%) had returned to sport; 17 (68%) returned to the same or higher level of sport compared with the highest preinjury level. The median time to RTS was 16 months (range, 7-26 months). Elite unit military, competitive collegiate, and competitive high school athletes returned at a significantly higher proportion ( P < .046) than did recreational athletes. For all patients, the Tegner level at the final follow-up (median, 6; mean, 6.1 ± 2.7; range, 1-10) was significantly lower than that at the highest preinjury level ( P = .007). PROMs were significantly improved at the final follow-up compared with preoperative levels and reached or exceeded clinically meaningful differences. OCA revisions were performed in 2 patients (5%), and failures requiring total knee arthroplasty occurred in 2 patients (5%), all of whom were recreational athletes. Noncompliance was documented in 4 athletes (11%) and was 15.5 times more likely ( P = .049) to be associated with failure or a need for revision than for compliant patients. Conclusion: Large single-surface, multisurface, or bipolar shell OCA knee transplantations in athletes resulted in two-thirds of these patients returning to sport at 16 to 24 months after transplantation. Combined, the revision and failure rates were 10%; thus, 90% of patients were considered to have successful 2- to 4-year outcomes with significant improvements in pain and function, even when patients did not RTS.

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The long-term outcome of simple trapeziectomy

Journal of Hand Surgery (European Volume) ◽

10.1177/1753193418780898 ◽

2018 ◽

Vol 44 (2) ◽

pp. 146-150 ◽

Cited By ~ 11

Author(s):

Thomas F. M. Yeoman ◽

Oliver Stone ◽

Paul J. Jenkins ◽

Jane E. McEachan

Keyword(s):

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Level Of Evidence ◽

Term Outcome ◽

Long Term Outcome ◽

Sustained Improvement ◽

Patient Reported ◽

The Mean ◽

Joint Arthritis

The aim of this study was to investigate the long-term outcome of simple trapeziectomy by a single surgeon and to compare this with pre-operative function. Two hundred and five patients completed the shortened disabilities of the arm, shoulder and hand questionnaire (QuickDASH) and the EuroQoL five-dimensional questionnaire (EQ-5D) scores at a mean of 8.2 (range 3.5–17) years after simple trapeziectomy. There were no pre-operative scores available, so case controls were selected from our prospective database to compare pre- and post-operative patient-reported outcome measures. The mean QuickDASH score of the post-operative matched group was 37 (SD 17.0) and the mean EQ-5D was 0.56 (SD 0.31). The mean QuickDASH score of the pre-operative group was 54 (SD 17.0). The mean difference in QuickDASH between the pre- and post-operative groups was 17 (95% CI: 8 to 26, p = 0.0003). This study demonstrated a significant and sustained improvement in patient-reported function after simple trapeziectomy. It supports that simple trapeziectomy is a simple, safe and effective treatment for advanced trapeziometacarpal joint arthritis. Level of evidence: IV

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Health-related quality-of-life (HRQoL) analysis from a randomized phase II trial of androgen signaling inhibitors with or without androgen deprivation therapy (ADT) for castration-sensitive prostate cancer: LACOG 0415.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.64 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 64-64

Author(s):

Andrey Soares ◽

Diogo Assed Bastos ◽

Fabio A. B. Schutz ◽

Eduardo Cronemberger ◽

Murilo Luz ◽

...

Keyword(s):

Prostate Cancer ◽

Locally Advanced ◽

Patient Reported Outcome ◽

Abiraterone Acetate ◽

Outcome Data ◽

Rank Test ◽

Emotional Wellbeing ◽

Patient Reported ◽

Related Quality

64 Background: LACOG0415 is a 3-arm randomized trial evaluating ADT with abiraterone acetate plus prednisone (ADT+AAP), apalutamide alone (APA) or apalutamide with AAP (APA+AAP) for patients with locally-advanced, high-risk biochemical recurrence or metastatic castration-sensitive prostate cancer (ASCO 2020). In this trial, ADT+AAP and APA+AAP achieved the primary endpoint of percentage of patients with PSA ≤ 0.2 ng/mL at week 25. Apalutamide alone showed a high PSA decline > 50% rate, but did not achieve the pre-specified PSA threshold. Here we report patient-reported outcome data using Functional Assessment of Cancer Therapy-Prostate (FACT-P). Methods: HRQoL was measured in the overall population using the FACT-P questionnaire, comprising 5 subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SFWB), and prostate cancer subscale (PCS). Scores for each patient were measured at baseline and every four weeks until week 25. Questionnaire completion was defined as ≥ 1 question answered at an assessment time point. Analysis of HRQoL change from baseline and deterioration included only patients with baseline and ≥ 1 postbaseline score. Differences greater than 10-points in FACT-P total score and differences greater than 3-points in PWB, FWB, EWB, SFWB, and PCS scores were considered clinically significant. The time-to-event endpoint was estimated by Kaplan-Meier method and compared by stratified log-rank test. Results: 128 patients were included in LACOG0415 trial and 122 of them completed the HRQoL assessments (ranging from 95.3% at baseline to 79.7% at week 25). FACT-P and all subscales scores were similar for all three arms at baseline. There were no meaningful differences in FACT-P scores at baseline and at week 25 between the 3 arms. The subscales scores also showed no statistically differences at baseline and at week 25. Time to FACT-P deterioration did not show any statistically difference between three arms ( P=0.3371). Conclusions: ADT free alternatives with APA alone or APA+AAP did not show meaningful differences in HRQoL in patients with advanced castration-sensitive prostate cancer compared to ADT+AAP. The short follow-up period limited the ability to explore differences in HRQoL after 25 weeks. Larger studies with longer follow-up are needed to further evaluate HRQoL with ADT-free strategies. Clinical trial information: NCT02867020. [Table: see text]

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