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

Primary Purpose

Coxarthrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capsule repair
capsulectomy
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coxarthrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Direct anterior hip arthroplasty with capsule repair.

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 23, 2020
    Last Updated
    September 25, 2020
    Sponsor
    Bezmialem Vakif University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04570748
    Brief Title
    Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
    Official Title
    Effect of Capsular Repair on the Outcomes of Direct Anterior Total Hip Arthroplasty.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 30, 2020 (Anticipated)
    Primary Completion Date
    July 30, 2021 (Anticipated)
    Study Completion Date
    July 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bezmialem Vakif University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coxarthrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Direct anterior hip arthroplasty with capsule repair.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Surgery that the surgeon will not perform capsule repair after performing an initial capsulectomy during total hip arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Capsule repair
    Intervention Description
    Direct anterior hip arthroplasty with or without capsule repair
    Intervention Type
    Procedure
    Intervention Name(s)
    capsulectomy
    Intervention Description
    capsulectomy without repair
    Primary Outcome Measure Information:
    Title
    Pelvis magnetic resonance ımages(MRI) evaluation of patients who underwent direct anterior total hip arthroplasty
    Description
    The new capsule mass will be evaluated by an independent radiologist. adiologist will evaluate the volume of the new capsule structure in cubic millimeter
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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