Time to Total Hip Replacement After Supervised Exercise and Patient Education
This trial is active, not recruiting.
|Treatments||a 12 week supervised exercise program and patient education, patient education|
|Sponsor||Oslo University Hospital|
|Start date||March 2005|
|End date||May 2013|
|Trial size||109 participants|
|Trial identifier||NCT01338532, 03c-2011-NAR|
The purpose of this study is to evaluate the time to total hip replacement in patients with hip osteoarthritis going through both a supervised exercise program and patient education compared to patients going through patient education only.
The null hypothesis is: There are no differences in time to total hip replacement between patients with hip osteoarthritis who went through a 12 week supervised exercise program and patient education compared to patients who went through patient education only.
Material and methods:
109 patients with both symptomatically and radiographically verified hip osteoarthritis were included in this randomized controlled trial between april 2005 and october 2007. They were randomized to either a 12 week supervised exercise program and patient education (n=55) or patient education only (n=54).
Information on if and when total hip replacement is performed will be collected between April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will be collected directly from the study participants by telephone.
The main outcome is time to total hip replacement.
This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to evaluate the effect of supervised exercise and patient education.
The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Time to Total Hip Replacement surgery (THR)
time frame: 3.5 to 6 years after inclusion
Male or female participants from 40 years up to 80 years old.
Inclusion Criteria: - Between 40 and 80 years old with uni- or bilateral hip disability. - Hip pain for more then 3 months. - Harris Hip Score between 60 and 95. Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for total hip replacement surgery. - Radiographic verified hip OA (Danielsson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: < 4 mm < 70 years, < 3 mm ≥ 70 years, or 1 mm difference between hips). Exclusion Criteria: - Patients who have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA). - Patients with co-morbidities not tolerating physical activities
|Official title||Time to Total Hip Replacement in Patients With Hip Osteoarthritis Going Through Both Supervised Exercise and Patient Education Compared to Those Going Through Patient Education Only. A 3.5-6 Year Follow-up of a Randomized, Controlled, Clinical Trial.|
|Principal investigator||May Arna Risberg, PT, PhD|
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