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Osteoarthritis, Knee clinical trials

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NCT ID: NCT05649995 Completed - Clinical trials for Osteo Arthritis Knee

Effectiveness of Pain Science Education in People With Symptomatic Knee Osteoarthritis

Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effectiveness of the program integrated with pain science education for people with painful knee osteoarthritis (OA). Another purpose of the study is to evaluate whether the program integrated with pain science education is more effective than the program integrated with biomedical education.

NCT ID: NCT05644639 Recruiting - Clinical trials for Osteoarthritis, Knee

Study of StimRouter for Chronic Knee OA Pain

GLEAM
Start date: October 18, 2022
Phase:
Study type: Observational

The goal of this study is to evaluate the use of StimRouter Neuromodulation System (StimRouter) in adult subjects with an established diagnosis of primary femorotibial osteoarthritis in the target knee (Kellgren-Lawrence ≥1) who have surgical contraindications to undergo a knee joint arthroplasty procedure. The main questions it aims to answer are: 1. To assess the effect of the StimRouter Neuromodulation System to manage joint pain in patients with symptomatic OA of the knee who are surgically contraindicated to undergo a knee joint arthroplasty 2. To assess the effect of StimRouter on joint stiffness, function and patient quality of life Participants will have StimRouter leads implanted then clinic visits will be scheduled for follow-up at Week 2, Month 3 and Month 6 (End of Study (EOS) or Early Termination (ET)).

NCT ID: NCT05644496 Recruiting - Clinical trials for Osteoarthritis, Knee

ZYNRELEF for Pain Management in Total Knee Arthroplasty

Start date: March 9, 2023
Phase: Phase 4
Study type: Interventional

The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: - How well does the study drug control pain in the days after surgery? - Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.

NCT ID: NCT05642260 Recruiting - Clinical trials for Osteo Arthritis Knee

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

Start date: January 8, 2023
Phase: N/A
Study type: Interventional

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

NCT ID: NCT05638893 Completed - Knee Osteoarthritis Clinical Trials

Metformin as Adjuvant Therapy in Obese Knee Osteoarthritis Patients

Start date: February 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study aims to evaluate the possible efficacy and safety of addition of metformin to celecoxib in patients with knee osteoarthritis.

NCT ID: NCT05636059 Completed - Knee Osteoarthritis Clinical Trials

Physiotherapy in Knee Osteoarthritis

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Osteoarthritis symptoms can be managed with non-drug treatments such as patient education, exercise or weight loss interventions. Cryotherapy is one of the effective method to reduce joint inflammation, pain and improve function. Another method is joint mobilization, which can also reduce pain and improve function. Based on this theory, it was hypothesized that cryotherapy will have better effect on pain and the quality of life, whereas joint mobilization will be more effective on knee function. The aim of the study was to compare the effects of different physiotherapy methods on pain, knee joint function and quality of life in individuals with osteoarthritis.

NCT ID: NCT05633849 Completed - Knee Osteoarthritis Clinical Trials

Evaluation of the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis

GAUDÍ
Start date: May 30, 2018
Phase: N/A
Study type: Interventional

The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish sites. Eligible patients were adults younger than 68 years diagnosed with symptomatic knee Osteoarthritis and pain score (VAS) ≥ 5. The primary endpoint was the change in pain from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.

NCT ID: NCT05632783 Withdrawn - Knee Osteoarthritis Clinical Trials

TreatMent Of Knee osTeoarthritis wIth chONdroitin Sulfate - the OA MOTION Study

MOTION
Start date: December 2023
Phase: Phase 3
Study type: Interventional

The goal of this phase III study is to evaluate the efficacy, safety, and tolerability of chondroitin sulfate 800 mg oral tablets versus placebo in the treatment of subjects with pain due to knee OA (osteoarthritis). The further aims of the study are to evaluate the durability of the treatment effect (up to week 36) and to gain further long-term safety and efficacy data (up to 48 weeks). The primary outcome of interest will be the effect of chondroitin sulfate on pain in the index knee at week 24 compared to placebo. The effect of chondroitin sulfate in the index knee functionality and the patient global impression of changes at 24 weeks compared to placebo are included as key-secondary endpoints. An additional key secondary endpoint will assess the durability of the effect on pain compared to placebo at week 36. Several additional secondary endpoints are included to further support the beneficial effect of the treatment and the improvements in patient's quality of life (i.e., Western Ontario and McMaster Universities Arthritis Index -WOMAC- subscales and total scores at each study visits, changes in patient's quality of life, use of rescue medication etc.) other than the safety of the product.

NCT ID: NCT05629715 Recruiting - Knee Osteoarthritis Clinical Trials

Conventional Instrumentation, Computer Navigation, and Robotic Assistance Techniques in TKA

Start date: June 1, 2025
Phase: N/A
Study type: Interventional

Knee osteoarthritis is a debilitating disease that can cause severe knee pain and significant limitations to patients' activities of daily living. Total knee arthroplasty (TKA), also known as knee replacement surgery, is a well-established and successful procedure for treatment of end-stage knee osteoarthritis. Over the years, TKA surgical techniques and implant technology have improved, resulting in better patient outcomes and implant survivorship. Despite continuous improvements being made to this high demand procedure, malalignment of component position is a well-known cause of post-operative complications, including knee pain, component loosening, and failure requiring revision surgery. Advanced techniques that utilize computer navigation or robotic-arm assistance have been developed in an attempt to avoid malalignment. Both technologies were created with the goal of improving the precision of implant positioning and implant sizing in order to improve lower limb alignment and joint line alignment. The OrthoAlign KneeAlign computer assisted navigation system is a commercially available device that uses gyroscopic limb position sensing technology mounted to intramedullary and extramedullary jigs to measure bone resection cuts in TKA that ultimately dictate implant position. The Zimmer Biomet ROSA Knee System is a commercially available, FDA-approved robotic assistant for performing TKA. It uses pre-operative x-rays to create a three-dimensional image of the patient's knee anatomy, which is used to create a pre-operative template of the implants to be used and provides intra-operative guidance for bone cuts during the TKA. The robotic system also assesses the soft tissue envelope around the knee and can assist with the soft tissue balancing of the knee arthroplasty. Alternatively, it can also be used in an imageless mode where bone cuts are performed based on intra-operative mapping using anatomic landmarks. To date, there have been no prospective studies comparing the implant positioning and patient outcomes directly of the KneeAlign system with the ROSA system and conventional TKA instrumentation techniques.

NCT ID: NCT05625178 Recruiting - Knee Osteoarthritis Clinical Trials

Effects of Vagus Nerve Stimulation on Central Pain Sensitivity & Parasympathetic Function in Knee Osteoarthritis

Start date: December 15, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the feasibility and effectiveness of transcutaneous vagus nerve stimulation (tVNS) to the ear on pain and autonomic function in people with knee osteoarthritis (OA). The main questions it aims to answer are: 1) whether tVNS is feasible to be used in people with knee OA; 2) whether tVNS demonstrates the trend in improving knee pain; and 3) whether tVNS has physiological effects on autonomic function (e.g., parasympathetic function) and pain perception in the central nervous system such as brain (i.e., central pain mechanisms). Participants will be asked to complete a battery of self-reported questionnaires about their demographic and behavioral information, ethnicity, pain, sleep, psychological/emotional symptoms. Subsequently, participants will complete baseline assessment where investigators will assess their knee pain severity, central pain sensitivity, and heart rate variability (a measurement for autonomic function). Then participants will receive a 60-minute tVNS. Investigators will redo the same assessment as baseline assessment after tVNS intervention to see the degree of knee pain, central pain sensitivity, and autonomic function changes. At the end of the study, investigators will assess their satisfaction level with the tVNS intervention and the feasibility of the intervention (e.g., completion rate, side effects).