Osteoarthritis Clinical Trial
Official title:
Reducing Postoperative Knee Flexion Contracture Recurrence by Correcting Leg Length Discrepancy in the Non-surgical Knee in Patients Undergoing Total Knee Arthroplasty for Primary Osteoarthritis: A Feasibility Study
Verified date | September 2022 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Moving one's joints through their full range of motion (ROM) is crucial for health and wellbeing. Those who are unable to do so have difficulty carrying out simple activities like walking or feeding themselves. Lost joint ROM is called a contracture. Osteoarthritis (OA) is the most common form of arthritis. About a third of people with knee OA develop knee flexion contractures (KFlCs), the inability to fully straighten the knee. Having a KFlC before a knee replacement is a big risk factor for redeveloping one after the operation. Many people with a KFlC in the knee for surgery also have a KFlC in the other knee. The investigators believe that this non-surgical KFlC increases the risk of re-developing a KFlC in the surgical knee after surgery by encouraging bending of the surgical knee to avoid one leg being shorter than the other. No one has ever looked at whether fixing this leg length difference using a shoe lift would prevent this problem and there is little information to help design such a study. Here the investigators will see if testing shoe lift use for preventing KFlC is feasible. The investigators hypothesis is that a study evaluating the benefit of using a shoe lift to correct leg length difference in the non-surgical knee is feasible.
Status | Completed |
Enrollment | 4 |
Est. completion date | March 2021 |
Est. primary completion date | March 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients scheduled for unilateral TKA for 1° OA will be assessed for eligibility. Those meeting the American College of Rheumatology criteria for knee OA and having bilateral knee flexion contractures (KFlCs) will be recruited. KFlC will be defined as a loss of knee extension of 6 or more degrees. Exclusion Criteria: - Exclusion criteria include TKA for cause other than primary OA, previous septic arthritis, history of inflammatory arthritis, previous condition or known connective tissue disease that is known to affect joint range of motion. |
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain assessed by visual analogue scale | Pain assessed by visual analogue scale | Baseline (pre-op recruitment) | |
Primary | Pain assessed by visual analogue scale | Pain assessed by visual analogue scale | 3 months post-knee replacement | |
Primary | Pain assessed by visual analogue scale | 6 months post-knee replacement | ||
Primary | Pain assessed by visual analogue scale | 12 months post-knee replacement | ||
Primary | Pain assessed by visual analogue scale | 24 months post-knee replacement | ||
Primary | Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC). | Pain assessed by pain subscales of KOOS and WOMAC. | Baseline (pre-op recruitment) | |
Primary | Pain assessed by pain subscales of Knee injury and Osteoarthritis Outcome Score (KOOS) and The Western Ontario and McMaster Universities Arthritis Index (WOMAC). | Pain assessed by pain subscales of KOOS and WOMAC. | 3 months post-knee replacement | |
Primary | Pain assessed by pain subscales of KOOS and WOMAC. | 6 months post-knee replacement | ||
Primary | Pain assessed by pain subscales of KOOS and WOMAC. | 12 months post-knee replacement | ||
Primary | Pain assessed by pain subscales of KOOS and WOMAC. | 24 months post-knee replacement | ||
Primary | Function assessed by function subscales of KOOS and WOMAC. | Function assessed by function subscales of KOOS and WOMAC. | 3 months post-knee replacement | |
Primary | Function assessed by function subscales of KOOS and WOMAC. | Function assessed by function subscales of KOOS and WOMAC. | 6 months post-knee replacement | |
Primary | Function assessed by function subscales of KOOS and WOMAC. | Function assessed by function subscales of KOOS and WOMAC. | 12 months post-knee replacement | |
Primary | Function assessed by function subscales of KOOS and WOMAC. | Function assessed by function subscales of KOOS and WOMAC. | 24 months post-knee replacement | |
Secondary | Bilateral knee range of motion measured using goniometer. | Measured using goniometer | Baseline (pre-op recruitment) | |
Secondary | Bilateral knee range of motion measured using goniometer. | Measured using goniometer | 3 months post-knee replacement | |
Secondary | Bilateral knee range of motion measured using goniometer. | Measured using goniometer | 6 months post-knee replacement | |
Secondary | Bilateral knee range of motion measured using goniometer. | Measured using goniometer | 12 months post-knee replacement | |
Secondary | Bilateral knee range of motion measured using goniometer. | Measured using goniometer | 24 months post-knee replacement | |
Secondary | 6-minute walk test | 6-minute walk test | 3 months post-knee replacement | |
Secondary | 6-minute walk test | 6-minute walk test | 6 months post-knee replacement | |
Secondary | 6-minute walk test | 6-minute walk test | 12 months post-knee replacement | |
Secondary | 6-minute walk test | 6-minute walk test | 24 months post-knee replacement | |
Secondary | Leg length | Clinical evaluation of leg length of both lower extremities | Baseline (pre-op recruitment) | |
Secondary | Leg length | Clinical evaluation of leg length of both lower extremities. Clinical leg length will be measured by a trained research assistant for both lower limbs with the patient supine, using a tape measurer from the anterior superior iliac spine to the medial malleolus with the knee maximally extended. | 3 months post-knee replacement | |
Secondary | Leg length | Clinical evaluation of leg length of both lower extremities. Clinical leg length will be measured by a trained research assistant for both lower limbs with the patient supine, using a tape measurer from the anterior superior iliac spine to the medial malleolus with the knee maximally extended. | 6 months post-knee replacement | |
Secondary | Leg length | Clinical evaluation of leg length of both lower extremities. Clinical leg length will be measured by a trained research assistant for both lower limbs with the patient supine, using a tape measurer from the anterior superior iliac spine to the medial malleolus with the knee maximally extended. | 12 months post-knee replacement | |
Secondary | Leg length | Clinical evaluation of leg length of both lower extremities. Clinical leg length will be measured by a trained research assistant for both lower limbs with the patient supine, using a tape measurer from the anterior superior iliac spine to the medial malleolus with the knee maximally extended. | 24 months post-knee replacement |
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