Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

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

Conditions
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Coxarthrosis

Intervention / Treatment
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* Procedure: Direct lateral approach in total hip arthroplasty
* Procedure: Anterior approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis of coxarthrosis Exclusion Criteria: Previous surgery on affected hip No mental disability preventing follow-up

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct lateral approach<br>Patient operated using direct lateral approach. | Procedure: Direct lateral approach in total hip arthroplasty<br>* The use of direct lateral approach in total hip arthroplasty<br>* Other names: Hardinge approach;|
| Active Comparator: Anterior approach<br>Patient operated using anterior approach. | Procedure: Anterior approach<br>* The use of anterior approach in total hip arthroplasty<br>* Other names: Smith-Petersen approach;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain | Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded. | First four postoperative days | 
| X-ray assessment | Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration. | 3 and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coxarthrosis, Hip arthroplasty, Anterior approach, Direct lateral approach, Hardinge approach, Smith-Petersen approach, Osteoarthrosis