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Clinical Trials/NCT01578746
NCT01578746
Unknown
Phase 4

Comparison Between Minimally Invasive Anterior Approach and Direct Lateral Approach in Total Hip Arthroplasty - A Prospective Randomized Trial

Sorlandet Hospital HF1 site in 1 country120 target enrollmentJanuary 2012
ConditionsCoxarthrosis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Coxarthrosis
Sponsor
Sorlandet Hospital HF
Enrollment
120
Locations
1
Primary Endpoint
Change in function
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2016
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sorlandet Hospital HF
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria

  • Previous surgery on affected hip
  • No mental disability preventing follow-up

Outcomes

Primary Outcomes

Change in function

Time Frame: 2 years

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.

Secondary Outcomes

  • Muscle damage(Day of operation and next four consecutive days)
  • Pain(First four postoperative days)
  • X-ray assessment(3 and 12 months)
  • MRI(3 and 12 months)

Study Sites (1)

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