scholarly journals Patient Reported Outcomes of Tenodesis to Reconstruct Peroneal Tendon Tears

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0019
Author(s):  
Natalie Danna ◽  
James Rizkalla ◽  
Ermias Abebe ◽  
James Brodsky

Category: Ankle Introduction/Purpose: Peroneal tendon tears are a common cause of lateral ankle pain. When the tear involves more than 50% of the tendon’s cross-sectional area, the treatment algorithm recommends tenodesis of the torn peroneal tendon to the intact peroneal tendon. Previous assessments in the literature of functional outcomes after peroneal tenodesis have widely used the American Orthopedic Foot and Ankle Score (AOFAS) survey as a measurement tool. However, this score was not designed for patient-reported outcomes and its validity and reliability have been questioned. The Medical Outcomes Shortform-36 (SF-36) and PROMIS are tools that have been extensively studied and validated. We sought to assess patient outcomes after peroneal tenodesis using validated tools: SF-36, PROMIS and AOS Disability scores. Methods: Prospective data was collected on patients undergoing peroneal tenodesis for peroneal tendon tears, and who follow up of at least one year. Patients who underwent concomitant procedures (hindfoot fusion, total ankle arthroplasty) were excluded from the study. Baseline patient-reported outcomes (PRO) scores were obtained preoperatively and compared to scores obtained at one year postoperatively. Results: We identified seventeen patients who underwent peroneal tenodesis for peroneal tendon tears. Average age was 62.1 years. SF-36 Physical Function scores increased from an average of 42.0 preop to 60.0 postop (p = 0.0095). PROMIS scores increased from 40.3 to 42.7 (p = 0.3049). There was no statistically significant improvement in postoperative SF-36 Pain scores (p = 0.3216). AOS Disability Scores dropped from 49.6 preop to 38.2 postop (p = 0.3178). AOS Pain scores decreased from 40.7 to 27.0 (p = 0.1779). Total AOS score decreased from 45.1 to 32.6 (p = 0.2204). Conclusion: The SF-36 Physical Function score, which is a validated outcome measure, showed statistically significant improvement postoperatively. Some of the other PROs for peroneal tenodesis failed to show statistically significant improvements, and this is most likely due to low numbers, rendering the cohort somewhat under-powered. Though the data is preliminary, the non-significant scores trended toward improvement. Despite the preliminary nature of this study, satisfactory outcomes of peroneal tenodesis using validated patient-reported outcome scores are demonstrated for the first time. Further study is underway to enlarge the scope of this investigation.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 994.2-995
Author(s):  
A. Sebba ◽  
J. Han ◽  
S. Mohan

Background:Significant improvements in pain and other patient-reported outcomes (PROs) have been shown in large clinical trials in patients with rheumatoid arthritis (RA) who receive tocilizumab (TCZ) compared with placebo (PBO). Recent data suggest that pain in RA may be noninflammatory as well as inflammatory, and improvement in pain scores and other PROs may be seen in patients who do not respond to treatment based on disease activity measures that evaluate inflammation.Objectives:To assess changes in pain scores and other PROs in patients with RA who did or did not achieve ≥ 20% improvement in SJC in TCZ clinical trials.Methods:Data from patients with active RA who received intravenous TCZ 8 mg/kg + MTX or PBO + MTX in 3 Phase III studies (OPTION [NCT00106548], TOWARD [NCT00106574] and LITHE [NCT00109408]) were included. All patients had moderate to severe RA with an inadequate response or intolerance of MTX (OPTION, LITHE) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TOWARD). Changes in pain (visual analog scale [VAS], 0-100 mm), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3), 36-Item Short Form Survey (SF-36) physical component score (PCS) and mental component score (MCS; 0-50) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (0-52) from baseline to Week 24 were evaluated. Results were compared between patients receiving TCZ + MTX and those receiving PBO + MTX in both patients who achieved ≥ 20% improvement in SJC (responders) and those who did not (nonresponders). The changes from baseline were analyzed using a mixed model with repeated measures, including the following covariates and interactions: treatment, visit, baseline of endpoint, region, baseline DAS28 and interactions of visit with treatment and baseline of endpoint.Results:Data from 1254 responders (TCZ + MTX, n = 831; PBO + MTX, n = 423) and 620 nonresponders (TCZ + MTX, n = 225; PBO + MTX, n = 395) were included. Patients receiving TCZ + MTX had significantly greater improvement in pain scores and HAQ-DI compared with PBO + MTX in the responder group (–27.19 vs –16.77 and –0.55 vs –0.34, respectively;P< 0.0001 for both) and nonresponder group (–9.59 vs 2.53 and –0.20 vs 0.01;P< 0.0001 for both) at Week 24 (Figure 1). Similar results were seen at Week 16 in the nonresponder group (–11.06 vs –2.38 and –0.23 vs –0.04;P< 0.0001 for both) prior to initiation of rescue treatment. At Week 24 in the responder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS and MCS (9.16 vs 5.71 and 6.55 vs 3.79, respectively;P< 0.0001 for both) (Figure 2) and FACIT-Fatigue (8.39 vs 5.11;P< 0.0001). In the nonresponder group, patients receiving TCZ + MTX had significantly greater improvements compared with PBO + MTX in SF-36 PCS at Week 16 (3.81 vs 1.65;P= 0.0006) and Week 24 (4.42 vs 1.01;P< 0.0001) (Figure 2) and FACIT-Fatigue at Week 16 (3.82 vs 1.32;P= 0.0039) and Week 24 (3.90 vs 1.40;P= 0.0111).Conclusion:Patients with RA who received TCZ + MTX had significantly greater improvements in pain score and other PROs than those who received PBO + MTX regardless of whether they achieved ≥ 20% improvement in SJC. Clinical outcome at Week 24 correlated well with PROs, with a relatively larger improvement in pain score and other PROs in the responder group than in the nonresponder group; relative to PBO + MTX, these improvements appear numerically similar in the responder and nonresponder groups with consistently smaller difference between the groups in TCZ-treated arms. The consistent effect of TCZ on PROs in both responder and nonresponder groups warrants further study on the impact of TCZ on sources of pain independent of that caused by joint inflammation.Figure:Acknowledgments:This study was sponsored by Genentech, Inc. Support for third-party writing assistance, furnished by Health Interactions, Inc, was provided by Genentech, Inc.Disclosure of Interests:Anthony Sebba Consultant of: Genentech, Gilead, Lilly, Regeneron Pharmaceuticals Inc., Sanofi, Speakers bureau: Lilly, Roche, Sanofi, Jian Han Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Shalini Mohan Shareholder of: Genentech, Inc., Employee of: Genentech, Inc.


2019 ◽  
Vol 32 (11) ◽  
pp. 1063-1068 ◽  
Author(s):  
Robert C. Marchand ◽  
Nipun Sodhi ◽  
Hiba K. Anis ◽  
Joseph Ehiorobo ◽  
Jared M. Newman ◽  
...  

AbstractAlthough there are many studies on the alignment advantages when using the robotic arm–assisted (RAA) system for total knee arthroplasty (TKA), there have been questions regarding patient-reported outcomes. Therefore, the purpose of this study was to use this index to compare: (1) total, (2) physical function, and (3) pain scores for manual versus RAA patients. We compared 53 consecutive RAA to 53 consecutive manual TKAs. No differences in preoperative scores were found between the cohorts. Patients were administered a modified Western Ontario and McMaster Universities Osteoarthritis Index satisfaction survey preoperatively and at 1-year postoperatively. The results were broken down to: (1) total, (2) physical function, and (3) pain scores. Univariate analysis with independent samples t-tests was used to compare 1-year postoperative scores. Multivariate models with stepwise backward linear regression were utilized to evaluate the associations between scores and surgical technique, age, sex, as well as body mass index (BMI). Statistical analyses were performed with a p < 0.05 to determine significance. The RAA cohort had significantly improved mean total (6 ± 6 vs. 9 ± 8 points, p = 0.03) and physical function scores (4 ± 4 vs. 6 ± 5 points, p = 0.02) when compared with the manual cohort. The mean pain score for the RAA cohort (2 ± 3 points [range, 0–14 points]) was also lower than that for the manual cohort (3 ± 4 points [range, 0–11 points]) (p = 0.06). On backward linear regression analyses, RAA was found to be significantly associated with more improved total (β coefficient [β] −0.208, standard error [SE] 1.401, p < 0.05), function (β = 0.216, SE = 0.829, p < 0.05), and pain scores (β −0.181, SE = 0.623, p = 0.063). The RAA technique was found to have the strongest association with improved scores when compared with age, gender, and BMI. This study suggests that RAA patients may have short-term improvements at minimum 1-year postoperatively. However, longer term follow-up with greater sample sizes is needed to further validate these results.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0023
Author(s):  
Philip B. Kaiser ◽  
Alexander M. Crawford ◽  
Eric M. Bluman ◽  
Jeremy T. Smith ◽  
Christopher P. Chiodo

Category: Hindfoot, Heel pain, plantar fascia Introduction/Purpose: Physical therapy (PT) is an effective treatment modality for patients with plantar fasciitis (PF) however it is unclear how this compares to a home-based plantar fascia-stretching (HS) protocol. We hypothesized there would be no difference in pain scores or clinical outcomes in patients treated with formal PT compared to those who performed HS. Methods: Fifty-seven patients with PF for at least three months were enrolled in a prospective randomized controlled trial comparing formal PT, using any and all modalities deemed clinically necessary, to a standardized HS protocol. Pain scores using a visual analog scale (VAS) and clinical patient reported outcomes including the Foot and Ankle Ability Measures (FAAM) and the Short Form (36) Health Survey (SF-36) were recorded and analyzed at 6 weeks, 3 months, 6 months, and 1 year after treatment commenced. Results: There were no significant differences in pain scores (VAS) or patient reported outcomes (FAAM and SF-36) at any follow-up time point between patient groups. At 6-months pain scores had improved in both the HS group (35% decrease, p<0.001) and PT group (26% decrease, p=0.002) relative to baseline without a significant intergroup difference (p=0.32). FAAM- activities of daily living (ADL) scores improved 13.0% (p=0.005) in the HS group and 21.3% (p<0.001) in the PT group at 6-months relative to baseline without a significant intergroup difference (p=0.84). The Physical Component Summary (PCS) Scores of the SF- 36 demonstrated improvement at the six week, three month, and one year time points in both groups. Conclusion: A home-based stretching therapy program demonstrated equivalent improvements in pain scores and clinical outcomes compared to formal PT in the treatment of PF. Most patients with PF who perform daily plantar fascia stretching exercises can expect substantial durable clinical improvement in their symptoms.


2021 ◽  
Vol 2 (7) ◽  
pp. 540-544
Author(s):  
Mads Moss Jensen ◽  
Stefan Milosevic ◽  
Gustav Østerheden Andersen ◽  
Leah Carreon ◽  
Ane Simony ◽  
...  

Aims The aim of this study was to identify factors associated with poor outcome following coccygectomy on patients with chronic coccydynia and instability of the coccyx. Methods From the Danish National Spine Registry, DaneSpine, 134 consecutive patients were identified from a single centre who had coccygectomy from 2011 to 2019. Patient demographic data and patient-reported outcomes, including pain measured on a visual analogue scale (VAS), Oswestry Disability Index (ODI), EuroQol five-dimension five-level questionnaire, and 36-Item Short-Form Health Survey questionnaire (SF-36) were obtained at baseline and at one-year follow-up. Patient satisfaction was obtained at follow-up. Regression analysis, including age, sex, smoking status, BMI, duration of symptoms, work status, welfare payment, preoperative VAS, ODI, and SF-36 was performed to identify factors associated with dissatisfaction with results at one-year follow-up. Results A minimum of one year follow-up was available in 112 patients (84%). Mean age was 41.9 years (15 to 78) and 97 of the patients were female (87%). Regression showed no statistically significant association between the investigated prognostic factors and a poor outcome following coccygectomy. The satisfied group showed a statistically significant improvement in patient-reported outcomes at one-year follow-up from baseline, whereas the dissatisfied group did not show a significant improvement. Conclusion We did not identify factors associated with poor outcome following coccygectomy. This suggests that neither of the included parameters should be considered contraindications for coccygectomy in patients with chronic coccydynia and instability of the coccyx. Cite this article: Bone Jt Open 2021;2(7):540–544.


2013 ◽  
Vol 40 (4) ◽  
pp. 369-378 ◽  
Author(s):  
Michael E. Weinblatt ◽  
Arthur Kavanaugh ◽  
Mark C. Genovese ◽  
David A. Jones ◽  
Theresa K. Musser ◽  
...  

Objective.To assess the influence of fostamatinib on patient-reported outcomes (PRO) in patients with active rheumatoid arthritis and an inadequate response to methotrexate (MTX).Methods.Patients taking background MTX (N = 457) were enrolled in a phase II clinical trial (NCT00665925) and randomized equally to placebo, fostamatinib 100 mg twice daily (bid), or fostamatinib 150 mg once daily (qd) for 24 weeks. Self-administered PRO measures included pain, patient's global assessment (PtGA) of disease activity, physical function, health-related quality of life (HRQOL), and fatigue. Mean change from baseline and a responder analysis of the proportion of patients achieving a minimal clinically important difference were determined.Results.At Week 24, there were statistically significant improvements in pain, PtGA, physical function, fatigue, and the physical component summary of the Medical Outcomes Study Short Form-36 (SF-36) for fostamatinib 100 mg bid compared with placebo. Mean (standard error) changes from baseline in the fostamatinib 100 mg bid group versus the placebo group were −31.3 (2.45) versus −17.8 (2.45), p < 0.001 for pain; −29.1 (2.26) versus −16.7 (2.42), p < 0.001 for PtGA; −0.647 (0.064) versus −0.343 (0.062), p < 0.001 for physical function; 7.40 (1.00) versus 4.50 (0.94), p < 0.05 for fatigue; 8.52 (0.77) versus 4.90 (0.78), p < 0.01 for SF-36 physical component score; and 3.99 (0.93) versus 3.71 (0.99), p = 0.83 for SF-36 mental component score. Patients receiving fostamatinib 150 mg qd showed improvements in some PRO, including physical function.Conclusion.Patients treated with fostamatinib 100 mg bid showed significant improvements in HRQOL outcomes.


2019 ◽  
Vol 7 (5) ◽  
pp. 232596711984692 ◽  
Author(s):  
Christina J. Hajewski ◽  
Natalie A. Glass ◽  
Robert W. Westermann ◽  
Matthew Bollier ◽  
Brian R. Wolf ◽  
...  

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to capture patient-reported outcomes (PROs) in an efficient manner. Few studies have assessed this instrument postoperatively. Purpose: To compare the PROMIS Physical Function computer adaptive test (PROMIS PF CAT) and Upper Extremity (PROMIS UE) item bank to other previously validated PRO instruments and to evaluate ceiling and floor effects and construct validity responsiveness in patients who underwent operative interventions for shoulder instability. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 72 patients who underwent operative interventions for shoulder instability completed the American Shoulder and Elbow Surgeons (ASES) assessment form, Marx shoulder activity scale (Marx), 36-Item Short Form Health Survey physical function (SF-36 PF) and general health (SF-36 GH), Western Ontario Shoulder Instability Index (WOSI), PROMIS PF CAT, and PROMIS UE before surgery and then at 6 weeks and 6 months postoperatively. Correlation coefficients were calculated among these tools. The effect size of change was also calculated for each tool at each time point. A total of 91 patients who had also undergone surgery for shoulder instability completed these PRO instruments 2 years postoperatively. The percentage of patients hitting the ceiling and floor effects of each of the PRO instruments was calculated at all time points. Results: The PROMIS PF CAT demonstrated excellent-good correlation with the SF-36 PF at all postoperative time points (0.61 at 6 weeks, 0.68 at 6 months, and 0.64 at 2 years; P < .01 for all). The PROMIS UE showed excellent correlation with the ASES at 6 weeks postoperatively (0.73, P < .01). Both the PROMIS PF CAT and PROMIS UE demonstrated the ability to detect change after surgical interventions with a medium to large effect size. The PROMIS UE demonstrated a ceiling effect at 6 months (68.1%) and 2 years (67.0%) postoperatively. The PROMIS PF CAT demonstrated no ceiling effect at any time point. Conclusion: The PROMIS PF CAT demonstrated good to excellent correlation with other previously validated PRO instruments that assess physical function in patients with shoulder instability postoperatively. The PROMIS UE demonstrated good correlation with other PRO tools but had a significant ceiling effect and is not recommended for this patient population. Both tools demonstrated an ability to detect change after surgical interventions with a good effect size.


2019 ◽  
Vol 4 (1) ◽  
pp. 247301141881302
Author(s):  
James R. Lachman ◽  
Jania Arcia Ramos ◽  
Samuel B. Adams ◽  
James A. Nunley ◽  
Mark E. Easley ◽  
...  

Background: Metal component failure in total ankle arthroplasty (TAA) is difficult to treat. Traditionally, conversion to an arthrodesis has been advocated. Revision TAA surgery has become more common with availability of revision implants and refinement of bone-conserving primary implants. The goal of this study was to analyze the clinical results and patient-reported outcomes for patients undergoing revision total ankle arthroplasty. Methods: We retrospectively reviewed prospectively collected data on 52 patients with a mean age of 63.5 ± 9.6 years who had developed loosening or collapse of major metal components following primary TAA. These patients were compared to a case-matched control group of 52 primary TAAs performed at the host institution with a minimum of 2 years’ follow-up. Cases of isolated polyethylene exchange, infection, or extra-articular realignment procedures were excluded. The American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score, Short Form 36 (SF-36), Short Musculoskeletal Function Assessment (SMFA), and pain scores were prospectively collected. Clinical data was collected through review of the electronic medical record to identify reasons for clinical failure, where clinical failure was defined as second revision or conversion to arthrodesis or amputation. Results: The identified causes of failure of primary TAA were aseptic loosening of both components (42%), talar component subsidence/loosening (36%), coronal talar subluxation (12%), tibial loosening (8%), and talar malrotation (2%). Thirty-one patients (59.5%) underwent revision of all components, 20 (38.5%) just the talar and polyethylene components, and one (2%) the tibial and polyethylene components. The average time to revision was 5.5 years ± 5.4 with a follow-up of 3.1 years ± 1.5 after revision. Eleven (21.2%) revision arthroplasties required further surgery: 6 required conversion to arthrodesis and 5 required second revision TAA. Pain scores, SF-36 scores, SMFA scores, and AOFAS Hindfoot scores all improved after revision surgery but never reached the same degree of improvement seen after primary TAA. Conclusions: Clinical and patient-reported outcomes of revision ankle arthroplasty after metal component failure significantly improved after surgery, although the recovery time was longer. In this series, 21.2% of revision TAAs required a second revision TAA or arthrodesis surgery. Various prostheses performed similarly when used for revision surgery. Revision TAA can offer significant improvements postoperatively. Level of Evidence: Level III, therapeutic.


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