Anterior Capsulectomy vs. Repair in Direct Anterior THA

NCT ID: NCT01621932

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2017-08-02

Brief Summary

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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

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Conditions

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Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical approach 1

Direct anterior surgical approach with capsulectomy

Group Type ACTIVE_COMPARATOR

Direct anterior approach with capsulectomy

Intervention Type PROCEDURE

Direct anterior approach with capsulectomy

Surgical approach 2

Direct anterior approach without capsulectomy

Group Type ACTIVE_COMPARATOR

Direct anterior approach without capsulectomy

Intervention Type PROCEDURE

Direct anterior approach without capsulectomy

Interventions

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Direct anterior approach with capsulectomy

Direct anterior approach with capsulectomy

Intervention Type PROCEDURE

Direct anterior approach without capsulectomy

Direct anterior approach without capsulectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Masonis, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina, P.A.

Locations

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OrthoCarolina, P.A.

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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101105A

Identifier Type: -

Identifier Source: org_study_id

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