scholarly journals Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e056382
Author(s):  
Xiaoqian Liu ◽  
Sarah Robbins ◽  
Xia Wang ◽  
Sonika Virk ◽  
Karen Schuck ◽  
...  
Keyword(s):  
Stem Cell ◽  
Cost Effectiveness ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Controlled Trial ◽  
Symptomatic Relief ◽  
Phase Iii ◽  
Pain Patient ◽  
Structural Improvement ◽  
The University

IntroductionKnee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months.Methods and analysisThe Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat.Ethics and disseminationThis protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications.Trial registration numbersAustralian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

Economic Analysis of Tirilazad Mesylate for Aneurysmal Subarachnoid Hemorrhage: Economic Evaluation of a Phase III Clinical Trial in Europe and Australia

1998 ◽  
Vol 14 (1) ◽  
pp. 145-160 ◽  
Author(s):  
Henry Glick ◽  
Richard Willke ◽  
Daniel Polsky ◽  
Ted Llana ◽  
Wayne M. Alves ◽  
...  
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Cost Effectiveness ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Controlled Trial ◽  
Cost Of Care ◽  
Phase Iii ◽  
Double Blind ◽  
Additional Information ◽  
Tirilazad Mesylate ◽  
The Cost

AbstractThis study used data from a multinational phase III randomized, double-blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox®) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.

scholarly journals Effectiveness of a Program Combining Strengthening, Stretching, and Aerobic Training Exercises in a Standing versus a Sitting Position in Overweight Subjects with Knee Osteoarthritis: A Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4113
Author(s):  
Betsy Denisse Perez-Huerta ◽  
Belén Díaz-Pulido ◽  
Daniel Pecos-Martin ◽  
David Beckwee ◽  
Enrique Lluch-Girbes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Controlled Trial ◽  
Exercise Program ◽  
Control Group ◽  
Global Increase ◽  
Experimental Group ◽  
Overweight Subjects

There is an increasing incidence, prevalence, and burden of knee osteoarthritis due to a global increase in obesity and an aging population. The aim of the present study was to compare the effectiveness of the addition of aerobic exercises performed in an unloaded or loaded position to a conventional exercise program in overweight subjects with knee osteoarthritis. Twenty-four subjects were randomly allocated to receive 36 sessions of 30-min duration of either sitting aerobic exercises (experimental group) or standing aerobic exercises (control group). Pain intensity, knee disability, and quality-of-life data were collected at baseline and at 12, 24, and 36 sessions. Generalized linear mixed models (GLMMs) were constructed for the analysis of the differences. Significant differences were found in the experimental group for self-reported pain and knee pain and disability at 24 and 36 sessions (p < 0.05). Significant between-group differences were observed in change in self-reported knee pain and disability and quality of life from baseline to 24th- and 36th-session measurements in favor of the experimental group. Adherence to treatment was higher in the experimental group. Adding aerobic exercises in an unloaded position to a conventional exercise program produced superior effects over time for self-reported knee pain, knee pain and disability and quality of life compared to loaded aerobic exercises in overweight subjects with knee osteoarthritis.

scholarly journals Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017652 ◽  
Author(s):  
Christelle Nguyen ◽  
Isabelle Boutron ◽  
Gabriel Baron ◽  
Emmanuel Coudeyre ◽  
Francis Berenbaum ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
The Mean ◽  
Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

scholarly journals Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multicentre, primary care, randomised, parallel-group, superiority trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e048196
Author(s):  
Melanie A Holden ◽  
Michael Callaghan ◽  
David Felson ◽  
Fraser Birrell ◽  
Elaine Nicholls ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Analysis Of Covariance ◽  
Written Information ◽  
Parallel Group ◽  
Management Protocol ◽  
Adherence Support ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee

BackgroundBrace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.Methods and analysisA multicentre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy and treatment acceptability will occur at 3, 6, and 12 months postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.Ethics and disseminationNorth West Preston Research Ethics Committee, the Health Research Authority and Health and Care Research in Wales approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.Trial registration numberISRCTN28555470.

scholarly journals Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial

2017 ◽  
Vol 77 (2) ◽  
pp. 188-195 ◽  
Author(s):  
Raine Sihvonen ◽  
Mika Paavola ◽  
Antti Malmivaara ◽  
Ari Itälä ◽  
Antti Joukainen ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Medial Meniscus ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Meniscus Tear ◽  
Arthroscopic Partial Meniscectomy ◽  
Serious Adverse Events ◽  
Secondary Outcomes

ObjectiveTo assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus.MethodsIn this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35–65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out.ResultsIn the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, −4.3; 95% CI, −11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (−3.2; −8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (−0.4; −1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups.ConclusionsIn this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

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