Clinical trial NCT01338532: Time to Total Hip Replacement After Supervised Exercise and Patient Education
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Hip osteoarthritis
Exercise
Patient Education
Total Hip Replacement
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Status:

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Total Hip Replacement surgery (THR)
timeFrame: 3.5 to 6 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: NAR-Orthopedic Department, Oslo University Hospital & Hjelp24 NIMI
Study officials:
affiliation: NAR- Department of Orthopedics, Oslo University Hospital
name: May Arna Risberg, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015 Jan;74(1):164-9. doi: 10.1136/annrheumdis-2013-203628. Epub 2013 Nov 19.