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Knee Osteoarthritis clinical trials

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NCT ID: NCT04059744 Completed - Knee Osteoarthritis Clinical Trials

Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Title: Older adults' experience and acceptance of a 'gamified' rehabilitative device for Total Knee Arthroplasty Background: Total Knee Arthroplasty (TKA) is a common surgical procedure. Good post-operative rehabilitation is needed for successful functional recovery. Patients in our institution demonstrated reduced exercise compliance and accuracy during early post-operative rehabilitation. Root cause analysis identified 'reduced feedback', 'reduced care continuity' and 'lack of engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate new ways of care continuation and patient activation. In response, Fun-Knee™, an app-based innovation was created. Using 'gamification' of rehabilitative exercises, Fun-Knee™ guides and tracks rehabilitation from post-surgery to after hospital discharge, till outpatient physiotherapy review. The experience and opinions of older adults towards such 'gamified' rehabilitative technology is unknown. Purpose: This feasibility study aims to evaluate and develop Fun-Knee™, a novel, app-based rehabilitation device that 'gamifies' post-TKA exercises to improve exercise compliance, effectiveness, and patient activation. Our prototype of Fun-Knee™ was introduced to two cohorts of healthy older adults. Users' experience with hardware and software components of Fun-Knee™, and their acceptance of Fun-Knee™ for rehabilitation were surveyed. Feedback from the first cohort guided prototype refinement. User experience was re-evaluated in the second cohort. Methods: Community-dwelling adults with no knee pain, 50 years old and above were recruited if they met inclusion criteria. Participants were introduced to two 'gamified' exercises within Fun-Knee™ with standardised instructions. They were instructed to complete one round of the two games at their own time. Thereafter, a survey consisting of quantitative responses was administered. Statistical analysis were performed using Stata (version 13.1, College Station, TX: StataCorp LP), Fisher's exact tests were performed 2-sided at the 5% significance level. Qualitative feedback was obtained during individual interview. Suggestions for hardware or software refinements to Fun-Knee™ were collated and implemented. The above process was repeated for the second cohort of participants, using the latest version of Fun-Knee™.

NCT ID: NCT04058002 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Project Arthritis Recovering Quality of Life Through Education 70+

PARQVE
Start date: August 15, 2019
Phase: N/A
Study type: Interventional

Introduction: Quadriceps weakness was previously associated with functional impairment of osteoarthritis (OA). Evidence also suggests that muscle strength may prevent the progression of existing OA. It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year beyond the age of 60 years. Therefore, procedures capable of increasing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA. The results of our studies have shown that with each year of life the patient loses strength gain capacity. Objective: To evaluate if a multiprofessional educational program associated with BCAA and creatine supplementation improves the quality of life, function, pain and body composition of patients with OA and age greater than or equal to 70 years. METHODS: 34 patients with knee OA and age greater than or equal to 70 years will undergo an educational and physical training program lasting 20 weeks. Half of the patients will receive creatine (control) and the others will receive creatine and BCAA (study). Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), and level of physical activity. All of the above parameters will be assessed at the beginning of the study and 6 and 12 months later. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.

NCT ID: NCT04057651 Completed - Knee Osteoarthritis Clinical Trials

Hip and Knee Scores

HIP-KNEE
Start date: August 28, 2018
Phase:
Study type: Observational

Patient-reported outcome measures (PROMs) are currently used for evaluating orthopaedic procedures. Nevertheless, there is no consensus in the different studies, making them difficult to compare . The score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score. Moreover , Minimal clinically important differences (MCID) is the smallest change in a treatment outcome that a patient would identify as important. The MCID is also not clearly identified for the French population for the hip and knee orthopaedic scores.

NCT ID: NCT04052308 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Decrease in Blood Pressure in PARQVE

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The tripod of OA clinical treatment is education, weight loss and exercise. A sedentary lifestyle has been characterized as an independent risk factor for cardiovascular disease. Studies have shown the inverse association between the level of physical activity and the incidence of cardiovascular disease. High Intensity Interval Training (HIIT), which consists of repeated high-intensity exercise sessions interspersed with passive recovery. Active, has been studied as a new therapeutic approach and has been shown to be effective in controlling blood pressure (BP) and arterial stiffness in treated hypertensive individuals. HIIT training has also been shown to be able to reverse the hemodynamic, metabolic and hormonal changes that are involved in the pathophysiology of essential hypertension, leading to improved arterial stiffness and BP response, endothelin-1 and nitrite / nitrate to exercise, increased cardiorespiratory fitness when compared to moderate-intensity continuous exercise in young women with a family history of essential hypertension. Six weeks of HIIT training (3 times / week) reduced body fat and waist circumference in young women. , while increasing fat-free mass, maximum running speed and aerobic fitness. Two recent studies evaluating body weight change in overweight patients have shown that HIIT training is comparable to moderate-intensity continuous exercise, but HIIT is more efficient compared to time spent training, which may facilitate the inclusion of daily routine training of patients. Previous work performed by the authors patients undergoing an education and physical activity program showed improvement in WOMAC. The investigators believe that the inclusion of an HIIT training protocol may lead to improved BP and hemodynamic variables in patients with knee osteoarthritis. To evaluate the effect of high intensity interval physical training associated with an educational program on BP, hemodynamic variables of individuals undergoing treatment for knee OA. 63 patients with knee OA will be randomized into 3 groups: interval exercise (21), continuous exercise (21) and control (21). Patients will be evaluated for BP using ABPM, arterial stiffness and endothelial reactivity by measuring carotid-femoral pulse wave velocity and quality of life using the Euroqol scale.

NCT ID: NCT04050111 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis

Start date: August 21, 2019
Phase: Phase 2
Study type: Interventional

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly. All patients will receive cell therapy.This is a single arm study with no control.

NCT ID: NCT04046003 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Tai Chi for Knee OA Pain Management: a Mechanistic Study

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study is to determine how 8-week Tai Chi intervention alters plasma endocannabinoid and its receptors in monocytes/marcrophages, plasma oxylipinds, plasma brain-derived neurotrophic factor, brain white matter connectivity/efficiency, and functional/clinical outcomes in women with knee OA.

NCT ID: NCT04044612 Completed - Knee Osteoarthritis Clinical Trials

Effect of Knee Bracing on Improving Pain & Disability

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The overall purpose of the proposed pilot study is to establish the feasibility of conducting a clinical trial by evaluating the preliminary effects of 8 weeks of knee bracing on physiological measures of self-reported pain and disability, physical performance, physical activity, as well as femoral cartilage deformation in individuals with medial compartment knee osteoarthritis (OA). The investigators will recruit 36 symptomatic knee OA patients for the pilot study. The investigators will evaluate a class of braces (two different models will be used) designed to correct genu varum. The purpose of the study is to evaluate changes in these novel outcomes following the use of a class of braces used to reduce medial tibiofemoral compartment compression used for 8 weeks. This pilot study will inform a larger future trial to determine the efficacy of bracing on decreasing disability and disease progression in patients with knee osteoarthritis.

NCT ID: NCT04043819 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis

Start date: September 7, 2019
Phase: Phase 1
Study type: Interventional

The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.

NCT ID: NCT04040764 Recruiting - Knee Osteoarthritis Clinical Trials

Uncemented Tritanium TKR vs Cemented Triathlon TKR

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

The Study aims to investigate whether there is a clinically important difference in peri-articular bone mineral density (BMD) and trabecular bone score (TBS) between patients undergoing two different types of knee replacement fixation - uncemented Tritanium total knee replacement (TKR) and cemented Triathlon TKR. Before undertaking a full randomised control trial however, it is necessary to establish that the proposed methodology and approach are feasible. Therefore an internal pilot study will be performed first. This registration is for the internal pilot study.

NCT ID: NCT04037345 Completed - Knee Osteoarthritis Clinical Trials

Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis

Start date: October 7, 2019
Phase: Phase 1
Study type: Interventional

This clinical trial is performed with patients with knee osteoarthritis who were radiologically diagnosed with Kellgren-Lawrence (K&L) grade 2 or 3. Subjects who voluntarily signed consent form and met inclusion/exclusion criteria, were evaluated eligible and participated in this trial. Investigator selected knee to be evaluated (right or left) and administered investigational product to selected knee on Day 1. A total of 3 or 6 subjects will be enrolled in low-dose or mid-dose group each, and 6 subjects will be enrolled in high-dose group. The study used a dose escalation scheme (from low-dose to high-dose) to determine the maximum tolerated dose (MTD).