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

NCT ID: NCT04570748

Last Updated: 2020-09-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coxarthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Direct anterior hip arthroplasty with capsule repair.

Group Type EXPERIMENTAL

Capsule repair

Intervention Type PROCEDURE

Direct anterior hip arthroplasty with or without capsule repair

Group B

Surgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty

Group Type ACTIVE_COMPARATOR

capsulectomy

Intervention Type PROCEDURE

capsulectomy without repair

Interventions

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Capsule repair

Direct anterior hip arthroplasty with or without capsule repair

Intervention Type PROCEDURE

capsulectomy

capsulectomy without repair

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Murat Sarikas

Recident of orthopaedic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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32495008292

Identifier Type: -

Identifier Source: org_study_id