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Knee Osteoarthritis clinical trials

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NCT ID: NCT06141018 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Effectiveness and Safety of Intra-articular SEMICAL GEL-B CROSS Therapy in Knee Osteoarthritis (SEM-ART1)

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effectiveness and safety of intra-articular injection of a cross-linked sodium hyaluronate; SEMICAL GEL-B CROSS, in knee osteoarthritis. Primary objectives: The aim of this study is to obtain short- and long-term clinical data on the performance and safety of intra-articular injection of SEMICAL GEL B-CROSS, produced and marketed by Semical Biosurgery incorporated company, in knee osteoarthritis patients. It is also aimed to monitoring known adverse events and complications, detecting previously unknown adverse events and complications, to identify and analyze emerging risks based on real-life data. Participants will receive intra-articular injection of either a cross-linked sodium hyaluronate (SEMICAL GEL-B CROSS); or placebo (isotonic saline solution) at baseline, and will be followed-up for one year to compare the effectiveness and safety of the given therapy.

NCT ID: NCT06135454 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Comparison of Outcomes Between Open Wedge High Tibial Osteotomy and Double Level Osteotomy in Antromedial Knee Arthritis With Extra Articular Deformity

Start date: December 10, 2024
Phase: N/A
Study type: Interventional

To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.

NCT ID: NCT06123689 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Safety and Efficacy of AMT-RegeneraActiva in the Management of Knee Osteoarthritis (OA)

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare in 60 patients suffering for Knee OA to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate Participants will [describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items]. Researchers will compare 2 Groups to see to demonstrate that AMT-RegeneraActiva is able to speed up the improvement process of knee osteoarthritis (OA) compared to Sodium Hyaluronate to pain management and improvement of functionality.

NCT ID: NCT06113549 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Grip on Knee Osteoarthritis; DIstraction Versus Arthroplasty

GODIVA
Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this pragmatic, open, (1:1) randomized, multi-centre, non-inferiority trial is to to determine whether knee-joint distraction (KD) is non-inferior on patient reported effectiveness as compared to a knee-prosthesis (KP; i.e. usual care) for relatively young patients with end-stage knee Osteoarthritis (OA). The main question[s] it aims to answer are: - Is KD non-inferior to KP regarding pain, function and stiffness (as indicated by the total score on the total Western Ontario and McMaster Universities Osteoarthritis Index' (WOMAC), with a non-inferiority limit of 15 points) at 2 years? - Is KD non-inferior to KP regarding Quality of Life (36-Item Short Form Health Survey, (SF36), Physical- and Mental- Component Summary (PCS/MCS), with a non-inferiority limit of 10 points) at 2 years? - Does KD lead to regeneration of tissue (increase in minimum joint-space-width > 0.05mm on x-ray) over 2 years? Participants will be allocated to undergo either a knee joint distraction or prosthesis (total- or unicompartmental KP according to orthopedic surgeon/patients discretion), and groups will be compared using will be compared between groups using (multivariable) random effects (mixed) modelling to account for the nested and longitudinal structure of the data over the 24 months follow-up. The stratification factors for randomization, center (using a random intercept) and gender, as well as a limited number of a priori defined prognostic factors (i.e. baseline WOMAC total score, age, BMI, severity of cartilage damage) will be accounted for in this analysis. The difference in mean total WOMAC score at 24 months between treatment groups will be estimated from this model with a 95% confidence interval (CI) and non-inferiority will be determined using the lower limit of this confidence interval.

NCT ID: NCT06103552 Not yet recruiting - Obesity Clinical Trials

BLOOM Forward: Investigating Weight Loss Impact on TJAC Patients

Start date: December 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to prospectively assess the efficacy of the BLOOM program, a comprehensive weight loss dietary and lifestyle program, in a population of patients living with obesity and awaiting hip or knee surgery. The main questions it seeks to answer are: 1. Can the BLOOM program support these patients to lose up to 10% of their initial body weight? 2. Will patients continue to lose weight for the next six months after completing the program? 3. Does the BLOOM program help patients to improve their overall quality of life? Study participants will undergo the BLOOM program, a virtual pre-operative weight management program that spans 24 weeks and is carefully supervised by medical professionals. They will be recruited at the LEAF Clinic after being referred by their primary care physician. During the BLOOM program, they will meet with a physician (initially, then once monthly) and a dietitian (initially, and then biweekly as part of virtual group coaching). They will have access to LEAF's online learning portal. These are normal elements of the BLOOM program. Furthermore, as part of their participation in the research study, participants will be asked to complete the following questionnaires: the Mediterranean dietary score, the Oxford Hip and Knee Questionnaire and the EQ-D5-5L quality of life assessment. They will complete these initially, and then at completion of the program and 3 and 6 months post-program. We will also collect their height and weight at these intervals.

NCT ID: NCT06090097 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Knee Biofeedback Rehabilitation Through Game Therapy

KneeBRIGHT
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this study is to learn about the effect of video-game based rehabilitation exercise for patients with knee osteoarthritis. The main question the study aims to answer is: do patients who exercise with the game have better functional outcomes and engagement compared to patients who do conventional exercise? Participants will complete 10 weeks of physical therapy exercise sessions that focus on quadriceps strengthening. Two sessions per week will be conducted in the clinic, and one session will be conducted at home each week. The interventional group will conduct all exercises using the KneeBRIGHT EMG sensors and game software. The control group will conduct all exercises following a standard physical therapy regimen. Researchers will compare knee function and engagement between the group who uses the game, and the group who does conventional exercise.

NCT ID: NCT06073106 Not yet recruiting - Breast Cancer Clinical Trials

Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

OPTIMA-C
Start date: December 2023
Phase:
Study type: Observational

The aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. This is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty. In this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.

NCT ID: NCT06063304 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

Start date: October 2023
Phase:
Study type: Observational

The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are: 1. Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression. 2. Compare the quantitative MRI measures developed with the results acquired from the following two questionnaires: Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS). 3. Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging 4. Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI Participants will be scanned at the 3T scanner at the Clinical Imaging Facility at Hammersmith Hospital and/or the 7T scanner at the LOCUS Center at St Thomas' Hospital. Knee osteoarthritis volunteers will be asked to fill out two questionnaires and will be scanned 4 times over a 2 year period (at enrolment, after 6 months, after 12 months and after 24 months) while healthy volunteers will be scanned once at enrolment. Both healthy volunteers and knee osteoarthritis patients will be asked to fill out MRI safety forms before entering the scanner room, and both groups will be scanned up to 90 minutes during each session. Researchers will compare knee osteoarthritis patients with healthy volunteers to see how their knee anatomy and tissue properties differ.

NCT ID: NCT06049342 Not yet recruiting - Knee Osteoarthritis Clinical Trials

A Trial to Evaluate the Safety, Tolerability, and Efficacy of NCR100 Injection in the Treatment of Subjects With KOA

NCR100
Start date: January 25, 2024
Phase: Phase 1
Study type: Interventional

This clinical study is to investigate the safety and efficacy of NCR100 injection in subjects with knee osteoarthritis (KOA). It is a dose-escalating, open label study in adult KOA subjects.

NCT ID: NCT06027697 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Prospective Evaluation of Subchondroplasty in Advanced Knee Osteoarthritis.

Start date: December 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis. The main question it aims to answer is: • Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ? Participants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement. This study will be conducted for 4 years.