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

NCT06831045 | Recruiting

• 1 other identifier: 20230334
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Wound Healing measured in number of 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

  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

  Score ranges from 0 to 10. Higher scores indicate worse scar cosmesis

  Up to 6 months

Secondary Outcomes (5)

• 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

  Up to 6 months

• Number of intraoperative fractures

  Up to 3 hours

• Length of surgery measured in minutes

  Up to 3 hours

• Number of postoperative complications

  Up to 90 days

Study Arms (2)

Bikini Incision Group

EXPERIMENTAL

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

Procedure: Bikini Incision

Longitudinal Incision Group

EXPERIMENTAL

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

Procedure: Longitudinal Incision

Interventions

Bikini Incision 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.

Bikini Incision Group

Longitudinal Incision 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.

Longitudinal Incision Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Study Officials

• Victor H Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor H Hernandez, MD

CONTACT

305-689-5195; vhh1@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Orthopedics

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)