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Clinical Trials/NCT04570748
NCT04570748UnknownNot Applicable

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

Bezmialem Vakif University0 sites160 target enrollmentStarted: November 30, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Primary Endpoint
Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A

Experimental

Direct anterior hip arthroplasty with capsule repair.

Intervention: Capsule repair (Procedure)

Group B

Active Comparator

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

Intervention: capsulectomy (Procedure)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Murat Sarikas

Recident of orthopaedic surgery

Bezmialem Vakif University

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