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Osteoarthritis clinical trials

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NCT ID: NCT05623215 Active, not recruiting - Knee Osteoarthritis Clinical Trials

ALknee Follow-up Study of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System

Start date: November 10, 2022
Phase:
Study type: Observational

The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary. The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.

NCT ID: NCT05618782 Active, not recruiting - Pain Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee

Start date: October 17, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, placebo-controlled trial of multiple doses and multiple administrations of LEVI-04 for the treatment of pain due to osteoarthritis of the knee.

NCT ID: NCT05566925 Active, not recruiting - Clinical trials for Osteoarthritis, Knee

Patients' Perceptions of Assessment and Treatment of Knee Osteoarthritis in Primary Care

Start date: November 22, 2022
Phase:
Study type: Observational

Background: To diagnose osteoarthritis (OA), Swedish guidelines recommend an overall assessment including patient history, symptoms, and clinical findings. However, diagnostic radiography is not recommended when assessing OA. Assessing and giving core treatments of patients with knee OA (KOA) is included in physiotherapists' area of expertise. Former studies show that there is no statistically significant difference in health-related quality of life for patients with KOA assessed by physiotherapists compared to being assessed by a physician in primary care. There is also research showing that costs can be reduced with a physiotherapist as first assessor. A task-shifting care model with physiotherapists as the primary assessor, can result in a reduced waiting time to recommended treatment for patients with KOA, as well as increase the accessibility to physicians in primary care for patients with more severe health conditions. Previous studies have explored expectations in patients with KOA and how they have experienced the health care when the first assessment and treatment has been performed by a physician. It has been described how referred patients with KOA have experienced physiotherapy treatment, and the physiotherapists' impact on exercise adherence. To the best of our knowledge, there are no studies describing how patients with KOA have experienced health care, when being referred directly to a physiotherapist for assessment and treatment. The main purpose is to explore expectations, perceptions, and experiences among patients with KOA in primary care who have been assessed and treated by a physiotherapist. The second purpose is to explore the possible meaning of the first meeting when it comes to future self-care and experienced health status. Methods: Estimated 12-15 patients with KOA will be recruited from rehabilitation centers in Region Västra Götaland, Sweden, from October 2022 to February 2023. Semi-structured interviews will be conducted and will be analyzed with qualitative content analysis. Expected results: This study is expected to contribute to a deeper understanding of what expectations patients with KOA have before they seek health care, how they experience physiotherapists as primary assessor in KOA and possible influences of the physiotherapy assessment and treatment on patients' perceived health after the rehabilitation period. This knowledge could be valuable when implementing new care models for patients with KOA.

NCT ID: NCT05550428 Active, not recruiting - Knee Osteoarthritis Clinical Trials

The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

A double-blinded, randomizepd controlled trial to investigate the treatment effects of pulsed electromagnetic field (PEMF) on end stage of knee osteoarthritis patients with sarcopenia will be carried out. Subjects will be recruited from the Prince of Wales Hospital. Sixty participants age ≥ 60 will be invited to join this trial after informed consent. They will be randomised to any of the 2 groups: intervention group (n=30; PEMF (Quantum Tx) treatment), and control group (n=30; sham treatment with dummy exposure to PEMF). Both group will receive home-based exercise. Baseline measurements include appendicular muscle mass by DXA, bone microarchitecture (XtremeCT II), knee flexion and extension strength by handheld dynamometer, knee flexion and extension range of motion by goniometer, self-reported knee pain (VAS) and function by The Knee Injury and Osteoarthritis Outcome Score (KOOS), International Physical Activity Questionnaire (IPAQ) for assessment of physical activity level, quality of life by SF-36, hand grip test, bioelectrical impedance analysis (BIA)of body composition, postural stability, chair stand test, 30s arm curl test and 6-meter walking test. These measurements will be performed again at middle and end of treatment, 3, 6, and 12 months after commencement of treatment, except DXA, which will not be performed at the midpoint. In addition, blood samples will be taken at baseline, middle, and end of treatment, 3, 6, and 12 months after commencement of treatment, for determing of serum myokines which are reported to be sensitive to PEMF treatment and contribute to myogenesis. The aim of this study is to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment on muscle gain and pain relief in knee osteoarthritis with sarcopenia elderly in Hong Kong. We hypothesize that PEMF treatment is effective to promote a gain in muscle mass and function and pain relief in knee osteoarthritis with sarcopenia elderlies.

NCT ID: NCT05543486 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Clinical Evaluation of the Levitation Knee Brace

Start date: August 19, 2021
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) is a debilitating disease affecting approximately 1/3 of Canadians over the age of 25. Knee OA typically involves at least 2 of 3 compartments in the knee joint. Conservative treatments include knee braces to manage symptoms and improve joint function. Most knee OA braces are designed to offload one knee compartment, but are not usually indicated for multicompartment knee OA. The Levitation Tri-compartment Offloader (TCO) knee brace stores energy during flexion and provides extension assistance to offload all 3 knee compartments. While there is strong preliminary evidence that the TCO can provide pain relief and improved knee function to users, it is critical to determine whether this brace will have similar benefits for patients with multicompartment knee OA. This pilot randomized control trial evaluates the clinical outcomes of using the TCO in comparison to the current conservative standard of care for knee OA patients.

NCT ID: NCT05470608 Active, not recruiting - Clinical trials for Osteoarthritis, Knee Pain

Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain

COMPASS
Start date: June 13, 2022
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose escalation study to assess the safety and efficacy of single treatment exposure of an injectable formulation of SL-1002 for the treatment of knee pain associated with osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to 168 days inclusive of a screening period of up to 28 days.

NCT ID: NCT05469776 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Bicruciate-retaining (2C) Total Knee Arthroplasty (TKA) Versus Posterior-stabilized (PS) Total Knee Arthroplasty (TKA)

Start date: November 1, 2011
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) with the sacrifice of the anterior cruciate ligament is the standard treatment for severe knee osteoarthritis. A number of studies on the kinematics of the prosthetic knee tend to show that implants that preserve the cruciate ligaments best reproduce the kinematics of the healthy knee. The goal is to compare the clinical and radiological results in patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis. Method: - Randomized controlled trial - Monocentric - Randomization will be done using sealed envelopes

NCT ID: NCT05449132 Active, not recruiting - Osteoarthritis Clinical Trials

Comparison of a Single RTX-GRT7039 and Placebo Intra-articular Injection for Pain Associated With Osteoarthritis of the Knee

Start date: August 26, 2022
Phase: Phase 3
Study type: Interventional

A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.

NCT ID: NCT05420441 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Chitosan Versus Glucosamine Phonophoresis in the Management of Knee Osteoarthritis

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

The study will be conducted to answer the following questions: - Is there an effect of phonophoresis using glucosamine on pain level , function and range of motion in knee osteoarthritis patients ? - Is there an effect of phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ? - Is there a difference between the effect of phonophoresis using glucosamine and phonophoresis using chitosan on pain level , function and range of motion in knee osteoarthritis patients ?

NCT ID: NCT05416255 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Measuring Synovial Fluid Components

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Participants with grade 3 and 4 knee osteoarthritis will recieve aspiration of synoivial fluid, and then receive either dextrose, hemaotopoietic stem cell, or platelet rich plasma, or no injection. The synovial fluid will be analyzed for changes in components.