Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.

September 25, 2020 updated by: Murat Sarikas, Bezmialem Vakif University

Total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis.

Recently, the direct anterior approach (DAA) has gained popularity by maintaining abduction force and reducing dislocation rates.

Soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the DAA.

The degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

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 or bilateral primary total hip arthroplasty
  • Direct anterior surgical approach
  • 18 years of age or older
  • Avascular necrosis of the hip

Exclusion Criteria:

  • Rheumatoid arthritis of the hip
  • Revision hip arthroplasty
  • Younger than 18 years of age
  • Crowe type 3 and 4 coxarthrosis

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: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Direct anterior hip arthroplasty with capsule repair.
Procedure: Capsule repair
Direct anterior hip arthroplasty with or without capsule repair
Active Comparator: Group B
Surgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty
Procedure: capsulectomy
capsulectomy without repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty
Time Frame: one year
The new capsule mass will be evaluated by an independent radiologist. adiologist will evaluate the volume of the new capsule structure in cubic millimeter
one year

Collaborators and Investigators

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

Sponsor

Bezmialem Vakif University

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 (Anticipated)

November 30, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32495008292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Coxarthrosis

Clinical Trials on Capsule repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe