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

Not Applicable

Recruiting

• Conditions: THA

• Registration Number: NCT06831045
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-17
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States