Recruiting

Bikini vs. Longitudinal

Sponsor:

University of Miami

Code:

NCT06831045

Conditions

THA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bikini Incision

Longitudinal Incision

Study Details

Brief summary:

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.

Conditions

THA

Study ID

NCT06831045

Start date

Mar 1, 2025

Status verified date

Mar, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bikini Incision Group

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

experimental: Longitudinal Incision Group

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

Interventions

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.

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.

Primary outcome measure

  • Wound Healing measured in number of days [ Time Frame: Up to 14 days ]
  • Patient satisfaction with scaring as measured by Patient Scar Assessment Scale [ Time Frame: Up to to 6 months ]
  • Scar cosmesis as measured by Observer Scar Assessment Scale [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Victor H Hernandez, MD

305-689-5195vhh1@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Jonathan M Stern, MD

305-243-1281jms188@miami.edu

Natalia Cruz-Ossa, MD

305-241-1281nxc971@miami.edu

Principal Investigator:

Victor H Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-18.