Bikini vs Longitudinal Incision in Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)

NCT ID: NCT06831045

Last Updated: 2025-03-19

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

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-04-01

Brief Summary

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The study team is conducting this study to see if there is a difference between the wound healing and participant satisfaction rates between two incision types used during a THA done via the DAA technique.

Detailed Description

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Conditions

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THA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bikini Incision Group

Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days.

Group Type EXPERIMENTAL

Bikini Incision

Intervention Type PROCEDURE

Participants will receive the bikini incision in person during THA. A one-time incision will be made along the groin line before standard of care THA surgery. The surgery takes approximately two hours.

Longitudinal Incision Group

Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days.

Group Type EXPERIMENTAL

Longitudinal Incision

Intervention Type PROCEDURE

Participants will receive the longitudinal incision in person during THA. A one-time linear incision will be made along the thigh before standard-of-care THA surgery. The surgery takes approximately two hours.

Interventions

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Bikini Incision

Participants will receive the bikini incision in person during THA. A one-time incision will be made along the groin line before standard of care THA surgery. The surgery takes approximately two hours.

Intervention Type PROCEDURE

Longitudinal Incision

Participants will receive the longitudinal incision in person during THA. A one-time linear incision will be made along the thigh before standard-of-care THA surgery. The surgery takes approximately two hours.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with body mass index greater than or equal to 30
* Patients undergoing primary unilateral DAA THA
* Patients undergoing primary THA

Exclusion Criteria

* Patients with body mass index less than 30
* Patients with a history of prior open surgery on the affected hip
* Patients unable/unwilling to undergo spinal anesthesia under monitored anesthesia care (MAC)
* Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
* The following groups will not be included: adults unable to consent, individuals who are not yet adults, pregnant women, prisoners.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Victor Hugo Hernandez

Professor of Clinical Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor H Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victor H Hernandez, MD

Role: CONTACT

305-689-5195

Facility Contacts

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Jonathan M Stern, MD

Role: primary

305-243-1281

Natalia Cruz-Ossa, MD

Role: backup

305-241-1281

Other Identifiers

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20230334

Identifier Type: -

Identifier Source: org_study_id

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