Comparison Between Anterior and Direct Lateral Approach in Total Hip Arthroplasty

NCT ID: NCT01578746

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Direct lateral approach

Patient operated using direct lateral approach.

Group Type: ACTIVE_COMPARATOR

Direct lateral approach in total hip arthroplasty

Intervention Type: PROCEDURE

The use of direct lateral approach in total hip arthroplasty

Anterior approach

Patient operated using anterior approach.

Group Type: ACTIVE_COMPARATOR

Anterior approach

Intervention Type: PROCEDURE

The use of anterior approach in total hip arthroplasty

Interventions

Direct lateral approach in total hip arthroplasty

The use of direct lateral approach in total hip arthroplasty

Intervention Type: PROCEDURE

Anterior approach

The use of anterior approach in total hip arthroplasty

Intervention Type: PROCEDURE

Other Intervention Names

Hardinge approach; Smith-Petersen approach

Eligibility Criteria

Inclusion Criteria

• Clinical and radiological diagnosis of coxarthrosis

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svein Andreas Svenningsen, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Sorlandet Hospital HF

Locations

Sorlandet Hospital HF

Arendal, , Norway

Countries

Norway

Other Identifiers

2011/2581 D

Identifier Type: OTHER

Identifier Source: secondary_id

811398

Identifier Type: -

Identifier Source: org_study_id