Anterior Capsulectomy vs. Repair in Direct Anterior THA

Sponsor

OrthoCarolina Research Institute, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT01621932

Collaborator

(none)

Enrollment

Location

Arms

65.1

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Procedure: Direct anterior approach with capsulectomy Procedure: Direct anterior approach without capsulectomy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Anterior Capsulectomy vs. Repair in Direct Anterior THA

Actual Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Aug 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgical approach 1 Direct anterior surgical approach with capsulectomy	Procedure: Direct anterior approach with capsulectomy Direct anterior approach with capsulectomy
Active Comparator: Surgical approach 2 Direct anterior approach without capsulectomy	Procedure: Direct anterior approach without capsulectomy Direct anterior approach without capsulectomy

Arm

Intervention/Treatment

Active Comparator: Surgical approach 1

Direct anterior surgical approach with capsulectomy

Procedure: Direct anterior approach with capsulectomy

Direct anterior approach with capsulectomy

Active Comparator: Surgical approach 2

Direct anterior approach without capsulectomy

Procedure: Direct anterior approach without capsulectomy

Direct anterior approach without capsulectomy

Outcome Measures

Primary Outcome Measures

Hip flexion [postoperative 4 months]

Secondary Outcome Measures

Visual analog scale-pain [4 months and 12 months post operative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OrthoCarolina, P.A.	Charlotte	North Carolina	United States	28207

Sponsors and Collaborators

OrthoCarolina Research Institute, Inc.

Investigators

Principal Investigator: John Masonis, MD, OrthoCarolina, P.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

OrthoCarolina Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT01621932

Other Study ID Numbers:

101105A

First Posted:

Jun 18, 2012

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Keywords provided by OrthoCarolina Research Institute, Inc.

Anterior approach

Study Results

No Results Posted as of Jan 26, 2021