Coxarthrosis Clinical Trial
Official title:
Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial
Verified date | June 2013 |
Source | Sorlandet Hospital HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Regional Ethics Commitee |
Study type | Interventional |
In total hip arthroplasty several approaches can be used. The newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. At the same time there are reports that there are more complications when this approach is used. The direct lateral approach is the most used in Norway and is well documented. There are however those who postulate that there is to high risk of damage to the gluteus medius causing Trendelenburg gait. In the investigators hospital both the anterior and direct lateral approach is used with good result. The investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (X-ray and MRI), markers for muscle damage (i.e CK-total) or other clinical outcomes.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Clinical and radiological diagnosis of coxarthrosis Exclusion Criteria: - Previous surgery on affected hip - No mental disability preventing follow-up |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Sorlandet Hospital HF | Arendal |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in function | Function of the operated hip will be evaluated after 3, 6, 12 and 24 months using Oxford Hip Score, Harris Hip Score and 6-minute-walk-test. Improvement in general health will be evaluated by using Eq-5D. | 2 years | No |
Secondary | Muscle damage | CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days. | Day of operation and next four consecutive days | No |
Secondary | Pain | Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded. | First four postoperative days | No |
Secondary | X-ray assessment | Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration. | 3 and 12 months | No |
Secondary | MRI | A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage. | 3 and 12 months | No |
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