Anterior Capsulectomy vs. Repair in Direct Anterior THA

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Direct anterior approach with capsulectomy; Procedure: Direct anterior approach without capsulectomy

• Registration Number: NCT01621932
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief Summary

Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.

The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Primary Completion: 2016-12
• Study Completion: 2017-08-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older

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Exclusion Criteria

• Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical approach 1	Direct anterior approach with capsulectomy	Direct anterior surgical approach with capsulectomy
Surgical approach 2	Direct anterior approach without capsulectomy	Direct anterior approach without capsulectomy

Primary Outcome Measures

Name	Time	Method
Hip flexion	postoperative 4 months

Secondary Outcome Measures

Name	Time	Method
Visual analog scale-pain	4 months and 12 months post operative

Trial Locations

Locations (1)

OrthoCarolina, P.A.; 🇺🇸 Charlotte, North Carolina, United States