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

March 17, 2026 updated by: Victor Hugo Hernandez, University of Miami

A Clinical Comparison in Wound Healing of Bikini Versus Longitudinal Incision in Direct Anterior Approach Total Hip Arthroplasty in the Obese Patient Population: A Randomized Control Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Victor H Hernandez, MD
  • Phone Number: 305-689-5195
  • Email: vhh1@miami.edu

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Victor H Hernandez, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bikini Incision Group
Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days.
Procedure: 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.
Experimental: Longitudinal Incision Group
Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing measured in number of days
Time Frame: Up to 14 days
Will be measured in number of days the incision will take to heal.
Up to 14 days
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
Time Frame: Up to to 6 months
Score ranges from 0 to 10. Higher scores indicate less satisfaction
Up to to 6 months
Scar cosmesis as measured by Observer Scar Assessment Scale
Time Frame: Up to 6 months
Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who report lateral femoral cutaneous nerve-related symptoms
Time Frame: Up to 6 months
Number of participants who report lateral femoral cutaneous nerve-related symptoms
Up to 6 months
Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes
Time Frame: Up to 6 months
Scores range from 0 to 28. Higher scores indicate worse patient reported outcomes
Up to 6 months
Number of intraoperative fractures
Time Frame: Up to 3 hours
Number of intraoperative fractures
Up to 3 hours
Length of surgery measured in minutes
Time Frame: Up to 3 hours
Length of surgery measured in minutes
Up to 3 hours
Number of postoperative complications
Time Frame: Up to 90 days
Number of postoperative complications
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Victor H Hernandez, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20230334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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