Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.

Not Applicable

• Conditions: Coxarthrosis
• Interventions: Procedure: Capsule repair; Procedure: capsulectomy

• Registration Number: NCT04570748
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.

Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.

Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.

The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-23
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Study First Posted: 2020-09-30
• Last Update Posted: 2020-09-30
• Study Start: 2020-11-30
• Primary Completion: 2021-07-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Elective unilateral or bilateral primary total hip arthroplasty
• Direct anterior surgical approach
• 18 years of age or older
• Avascular necrosis of the hip

Exclusion Criteria

• Rheumatoid arthritis of the hip
• Revision hip arthroplasty
• Younger than 18 years of age
• Crowe type 3 and 4 coxarthrosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group A	Capsule repair	Direct anterior hip arthroplasty with capsule repair.
Group B	capsulectomy	Surgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty	one year	The new capsule mass will be evaluated by an independent radiologist. adiologist will evaluate the volume of the new capsule structure in cubic millimeter