Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

2015 ◽  
Vol 45 ◽  
pp. 281-286 ◽  
Author(s):  
Leslie J. Bisson ◽  
Melissa A. Kluczynski ◽  
William M. Wind ◽  
Marc S. Fineberg ◽  
Geoffrey A. Bernas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Chondral Lesions ◽  
Randomized Controlled

How Does the Presence of Unstable Chondral Lesions Affect Patient Outcomes After Partial Meniscectomy? The ChAMP Randomized Controlled Trial

2017 ◽  
Vol 46 (3) ◽  
pp. 590-597 ◽  
Author(s):  
Leslie J. Bisson ◽  
Melissa A. Kluczynski ◽  
William M. Wind ◽  
Marc S. Fineberg ◽  
Geoffrey A. Bernas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Injury ◽  
Short Form ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Postoperative Outcomes ◽  
Level Of Evidence ◽  
Chondral Lesions ◽  
Randomized Controlled ◽  
Outcome Score

Background: Chondral lesions are commonly encountered during arthroscopic partial meniscectomy (APM); however, it is unknown how these lesions affect postoperative outcomes. Purpose: The authors compared postoperative outcomes among patients with and without unstable chondral lesions 1 year after APM. Study Design: Cohort study; Level of evidence, 3. Methods: The authors conducted a secondary analysis of data from the ChAMP (Chondral Lesions and Meniscus Procedures) randomized controlled trial. They compared the following outcomes for patients with unstable chondral lesions that were left in situ and observed (CL-noDeb) versus patients without unstable chondral lesions (NoCL) at 1 year after APM: Western Ontario and McMaster Universities Osteoarthritis Index, Knee injury and Osteoarthritis Outcome Score, visual analog scale for pain, the Short Form Health Survey, range of motion, quadriceps circumference, and effusion. Multivariate linear regression was used to obtain mean differences (MDs) with corresponding 95% CIs adjusted for age, body mass index, and preoperative score (for postoperative scores). Results: Compared with the CL-noDeb group, the NoCL group had greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index for pain (MD, 7.9, 95% CI: 2.7-13.1), stiffness (MD, 9.1, 95% CI: 1.9-16.3), and physical function (MD, 4.6, 95% CI: 0.1-9.0) and Knee injury and Osteoarthritis Outcome Score for pain (MD, 8.4, 95% CI: 2.7-14.0), function in sport and recreation (MD, 11, 95% CI: 3.0-19.1), and quality of life (MD, 10.4, 95% CI: 2.3-18.5). The NoCL group was less likely than the CL-noDeb group to have an effusion ( P = .02) 1 year after surgery. Conclusion: Patients undergoing APM without unstable chondral lesions had better outcomes than patients with unstable chondral lesions.

scholarly journals Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial

2020 ◽  
Vol 8 (10) ◽  
pp. 232596712095439
Author(s):  
Julia C.A. Noorduyn ◽  
Tess Glastra van Loon ◽  
Victor A. van de Graaf ◽  
Nienke W. Willigenburg ◽  
Ise K. Butter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Physical Therapy ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Patient Specific ◽  
Minimal Important Change ◽  
Meniscal Tears ◽  
Escape Trial ◽  
Randomized Controlled

Background: It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears. Purpose: To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients’ most important functional limitations as the outcome. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging–confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m2, locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method. Results: After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a –0.6-point difference (95% CI, –1.0 to –0.2; P = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale. Conclusion: Both interventions were associated with a clinically meaningful improvement regarding patients’ most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point. Registration: NCT01850719 ( ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).

scholarly journals The efficacy of intraarticular viscosupplementation after arthroscopic partial meniscectomy: a randomized controlled trial

2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Kyoung Ho Yoon ◽  
Woo Seung Wan ◽  
Yoon-Seok Kim ◽  
Jae-Young Park
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Partial Meniscectomy ◽  
Control Group ◽  
Arthroscopic Partial Meniscectomy ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Link Type ◽  
Post Surgery

Abstract Background This study aimed to evaluate the efficacy of viscosupplementation after arthroscopic partial meniscectomy. Method A randomized controlled trial of 47 patients who underwent arthroscopic partial meniscectomy was conducted between March 2020 and March 2021. Patients were randomized into two groups: a viscosupplementation group (n = 23) and a control group (n = 24). A single-dose intraarticular hyaluronic acid injection was used as viscosupplementation. The 100 mm visual analogue scale (VAS) for pain assessment was measured at baseline and at 1 day, 2 weeks, 6 weeks, and 3 months post-surgery. The International Knee Documentation Committee (IKDC), Tegner, Lysholm, and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores and range of motion (ROM) of the knee were measured at baseline, 2 weeks, 6 weeks, and 3 months. Results The 100 mm VAS score for pain was significantly lower in the viscosupplementation group at 2 weeks post-surgery (27.5 mm vs. 40.7 mm, P = 0.047). ROM was significantly greater in the viscosupplementation group than in the control group at 2 weeks (131.5° vs. 121.0°, P = 0.044) post-surgery. No significant differences were observed in the IKDC or in the Tegner, Lysholm, and WOMAC scores between the two groups. Conclusions Viscosupplementation after arthroscopic partial meniscectomy significantly reduced pain at 2 weeks post-surgery and improved ROM of the knee at 2 weeks post-surgery. There might be some benefits in terms of pain and functional recovery of viscosupplementation after arthroscopic surgery. Study design Randomized controlled trial; Level of evidence, 1. Trial registration This randomized controlled trial was registered at cris.nih.go.kr #KCT0004921.

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau
Keyword(s):  
Randomized Controlled Trial ◽  
Response Latency ◽  
Controlled Trial ◽  
Semantic Knowledge ◽  
Semantic Feature ◽  
Feature Analysis ◽  
Group Differences ◽  
Randomized Controlled ◽  
Confrontation Naming ◽  
Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

Baclofen versus clonidine in the treatment of opiates withdrawal, side-effects aspect: a double-blind randomized controlled trial

2001 ◽  
Vol 26 (1) ◽  
pp. 67-71 ◽  
Author(s):  
S. A. Ahmadi-Abhari ◽  
S. Akhondzadeh ◽  
S. M. Assadi ◽  
O. L. Shabestari ◽  
Z. M. Farzanehgan ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Controlled Trial ◽  
Double Blind ◽  
Randomized Controlled
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