Anterior Capsulectomy vs. Repair in Direct Anterior THA

January 25, 2021 updated by: OrthoCarolina Research Institute, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hip flexion
Time Frame: postoperative 4 months
postoperative 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale-pain
Time Frame: 4 months and 12 months post operative
4 months and 12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

August 2, 2017

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Actual)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 101105A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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