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

NCT04570748 | Unknown

• 1 other identifier: 32495008292
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coxarthrosis

Outcome Measures

Primary Outcomes (1)

• Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty

  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

Study Arms (2)

Group A

EXPERIMENTAL

Direct anterior hip arthroplasty with capsule repair.

Procedure: Capsule repair

Group B

ACTIVE COMPARATOR

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

Procedure: capsulectomy

Interventions

Capsule repair PROCEDURE

Direct anterior hip arthroplasty with or without capsule repair

Group A

capsulectomy PROCEDURE

capsulectomy without repair

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Recident of orthopaedic surgery

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: September 30, 2020
• Study Start: November 30, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2022
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share