Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

Phase 4

• Conditions: Coxarthrosis

• Registration Number: NCT01578746
• Lead Sponsor: Sorlandet Hospital HF

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-17
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-13
• Last Update Posted: 2013-06-14
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in function	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 Outcome Measures

Name	Time	Method
Muscle damage	Day of operation and next four consecutive days	CK-total is measured direct postoperativly and for the next four consequtive days. CRP is measured the first four postoperative days.
Pain	First four postoperative days	Pain using Visual Analog Scale and the use of analgetics (converted to opioid equivalent doses) are recorded.
X-ray assessment	3 and 12 months	Placement of the acetabular component (inclination and version) and femoral stem (varus/valgus) and migration.
MRI	3 and 12 months	A subselection of about 40 patients will undergo MRI-scans preoperatively and after 3 and 12 months to assess tendon- and muscledamage.

Trial Locations

Locations (1)

Sorlandet Hospital HF; 🇳🇴 Arendal, Norway