CClinicalTrials.gg
Status unknownNCT04570748Updated Sep 30, 2020

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

An interventional study of Capsule repair and capsulectomy in Coxarthrosis, sponsored by Bezmialem Vakif University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-30.

Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Coxarthrosis

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03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 160 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Bezmialem Vakif University is the lead sponsor of 345 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Group A

    Direct anterior hip arthroplasty with capsule repair.

    Procedure: 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

Interventions

  • ProcedureCapsule repair

    Direct anterior hip arthroplasty with or without capsule repair

  • Procedurecapsulectomy

    capsulectomy without repair

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What researchers measure

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

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04570748
Lead sponsor
Bezmialem Vakif University
Responsible party
Murat Sarikas (Recident of orthopaedic surgery, Bezmialem Vakif University) — Principal investigator
First posted
Sep 30, 2020
Start date
Nov 30, 2020 (estimated)
Primary completion
Jul 30, 2021 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Sep 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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