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 Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

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.

scholarly journals Treatment of Osteoarthritis with Autologous, micro fragmented Adipose Tissue: A study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background: Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro fragmented adipose tissue has been suggested to relieve symptoms.Methods/Design: The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grade 2 – 3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months, the Tegner activity score, treatment failure and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion: This trial is the first to investigate the efficacy of autologous, micro fragmented adipose tissue in a randomized controlled trial. The study uses the patient reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

scholarly journals Characterized Chondrocyte Implantation Results in Better Structural Repair when Treating Symptomatic Cartilage Defects of the Knee in a Randomized Controlled Trial versus Microfracture

2008 ◽  
Vol 36 (2) ◽  
pp. 235-246 ◽  
Author(s):  
Daniel B. F. Saris ◽  
Johan Vanlauwe ◽  
Jan Victor ◽  
Miroslav Haspl ◽  
Michael Bohnsack ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcome ◽  
Knee Injury ◽  
Controlled Trial ◽  
Cartilage Defects ◽  
Structural Repair ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Chondrocyte Implantation

Background As the natural healing capacity of damaged articular cartilage is poor, joint surface injuries are a prime target for regenerative medicine. Characterized chondrocyte implantation uses an autologous cartilage cell therapy product that has been optimized for its biological potency to form stable cartilage tissue in vivo. Purpose To determine whether, in symptomatic cartilage defects of the femoral condyle, structural regeneration with characterized chondrocyte implantation is superior to repair with microfracture. Study Design Randomized controlled trial; Level of evidence, 1. Methods Characterized chondrocyte implantation was compared with microfracture in patients with single grade III to IV symptomatic cartilage defects of the femoral condyles in a multicenter trial. Patients aged 18 to 50 years were randomized to characterized chondrocyte implantation (n = 57) or microfracture (n = 61). Structural repair was blindly assessed in biopsy specimens taken at 1 year using (1) computerized histomorphometry and (2) evaluation of overall histological components of structural repair. Clinical outcome was measured using the self administered Knee injury and Osteoarthritis Outcome Score. Adverse events were recorded throughout the study. Results Characterized chondrocyte implantation resulted in better structural repair, as assessed by histomorphometry ( P = .003) and overall histologic evaluation ( P = .012). Aspects of structural repair relating to chondrocyte phenotype and tissue structure were superior with characterized chondrocyte implantation. Clinical outcome as measured by the Knee injury and Osteoarthritis Outcome Score at 12 to 18 months after characterized chondrocyte implantation was comparable with microfracture at this stage. Both treatment groups had a similar mean baseline overall Knee injury and Osteoarthritis Outcome Score (56.30 ± 13.61 and 59.53 ± 14.95 for microfracture and characterized chondrocyte implantation, respectively), which increased in both groups to 70.56 ± 12.39 and 72.63 ± 15.55 at 6 months, 73.26 ± 14.66 and 73.10 ± 16.01 at 12 months, and 74.73 ± 17.01 and 75.04 ± 14.50 at 18 months, respectively. Both techniques were generally well tolerated; the incidence of adverse events after characterized chondrocyte implantation was not markedly increased compared with that for microfracture. Conclusion One year after treatment, characterized chondrocyte implantation was associated with a tissue regenerate that was superior to that after microfracture. Short-term clinical outcome was similar for both treatments. The superior structural outcome may result in improved long-term clinical benefit with characterized chondrocyte implantation. Long-term follow-up is needed to confirm these findings.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

scholarly journals Combined Hip Abductor and External Rotator Strengthening and Hip Internal Rotator Stretching Improves Pain and Function in Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial With Crossover Design

2021 ◽  
Vol 9 (4) ◽  
pp. 232596712198972
Author(s):  
Anis Jellad ◽  
Amine Kalai ◽  
Mohamed Guedria ◽  
Mahbouba Jguirim ◽  
Sana Elmhamdi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Patellofemoral Pain Syndrome ◽  
Patellofemoral Pain ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Group Standard ◽  
Hip Muscle ◽  
And Function

Background: Active rehabilitation has an important role in the management of patellofemoral pain syndrome (PFPS). Although some studies have shown the benefit of hip-muscle strengthening, the effect of combining hip-muscle stretching with strengthening has not yet been defined. Purpose: To evaluate the effect of combined strengthening of the hip external rotators and abductors and stretching of the hip internal rotators on pain and function in patients with PFPS. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 109 patients with PFPS (75 female and 34 male; mean age, 31.6 ± 10.8 years) were first randomly assigned to protocol A (n = 67) of the A-B arm (AB group; standard rehabilitation) or protocol B (n = 42) of the B-A arm (BA group; standard rehabilitation with strengthening of the hip external rotators and abductors and stretching of the hip internal rotators). Each protocol consisted of 3 sessions a week for 4 weeks. After a washout period, corresponding to a symptom-free period, rehabilitation programs were crossed over. A visual analog scale (VAS) evaluating perceived pain, the Functional Index Questionnaire (FIQ), and the Kujala score were administered at baseline, the end of each rehabilitation protocol, and 12 weeks after the completion of the second protocol for each group. Results: Until the final follow-up, VAS, FIQ, and Kujala scores were significantly improved in both the A-B and B-A arms ( P < .05 for all). Compared with protocol A, protocol B provided significant improvement in terms of pain and function in both the BA (VAS and Kujala; P < .001) and AB (VAS and Kujala; P < .001) groups. Conclusion: Combined strengthening of the hip abductors and external rotators with stretching of the hip internal rotators provided better outcomes, which were maintained for at least 12 weeks, in terms of pain and function in patients with PFPS.

The Therapeutic Effects of Acupuncture on Patients with Chronic Neck Myofascial Pain Syndrome: A Single-Blind Randomized Controlled Trial

2010 ◽  
Vol 38 (05) ◽  
pp. 849-859 ◽  
Author(s):  
Mei-Yuan Sun ◽  
Ching-Liang Hsieh ◽  
Yung-Yen Cheng ◽  
Hung-Chang Hung ◽  
Tsai-Chung Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Myofascial Pain ◽  
Short Form ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Myofascial Pain Syndrome ◽  
Randomized Controlled ◽  
Single Blind

Chronic neck myofascial pain syndrome (MPS) is a common disorder seen in clinics. There is no gold standard method to treat myofascial pain. We investigated the effects of acupuncture on patients with chronic neck MPS by a single-blind randomized controlled trial. A total of 35 patients were randomly allocated to an acupuncture group (AG) or a sham acupuncture group (SG). Each subject received acupuncture treatment twice per week for three consecutive weeks. The primary outcome measure was quality of life as assessed with Short Form-36, and secondary outcome measures were neck range of motion (ROM), motion-related pain, and Short-Form McGill Pain Questionnaire (SF-MPQ), as determined by a blinded investigator. The clinical assessments were made before treatment (BT) and after six acupuncture treatments (AT), as well as four weeks (F1) and 12 weeks (F2) after the end of the treatment. A total of 34 patients completed the trial. The results indicated that there is no significant difference in the ROM, motion-related pain, and SF-MPQ scores between AG and SG at AT, F1 and F2 (all p > 0.05). However, AG has greater improvement in physical functioning and role emotional of Short Form-36 quality of life at F2. The results indicate that acupuncture may be used to improve the quality of life in patients with chronic neck MPS.

scholarly journals Uncovering the Truth

2017 ◽  
Vol 12 (1) ◽  
pp. 49-50
Author(s):  
George E. Guthrie
Keyword(s):  
Randomized Controlled Trial ◽  
Basic Science ◽  
Healthy Lifestyle ◽  
Controlled Trial ◽  
Lifestyle Changes ◽  
Level Of Evidence ◽  
Lifestyle Medicine ◽  
Randomized Controlled ◽  
Standards Of Practice ◽  
Guidelines And Standards

Finding the truth is important. In the field of lifestyle medicine the randomized controlled trial has significant limitations. Physicians and patients need to know the truth about the healthy lifestyle changes and their ability to prevent and reverse disease. To meet this challenge, the American College of Lifestyle Medicine has established a committee of experts (HEaLM), under the leadership of David Katz to create a level of evidence construct for ranking lifestyle medicine evidence that includes evidence from basic science and epidemiologic trials. This tool will be used by the new Expert Lifestyle Medicine Panel to create guidelines and standards of practice.

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