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NCT01621932 Clinical Trial

Anterior Capsulectomy vs. Repair in Direct Anterior THA

Total Hip Arthroplasty Clinical Trial

Official title:
Anterior Capsulectomy vs. Repair in Direct Anterior THA

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01621932
Other study ID # 101105A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2012
Est. completion date August 2, 2017

Study information
Verified date January 2021
Source OrthoCarolina Research Institute, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date August 2, 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Direct anterior approach with capsulectomy
Direct anterior approach with capsulectomy
• Direct anterior approach without capsulectomy
Direct anterior approach without capsulectomy

Locations
Country Name City State
United States OrthoCarolina, P.A. Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hip flexion postoperative 4 months
Secondary Visual analog scale-pain 4 months and 12 months post operative
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