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NCT Number: NCT06831045

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

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.

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Key information

Conditions

THA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. Number of intraoperative fractures

    Time frame: Up to 3 hours

    Number of intraoperative fractures

  4. Length of surgery measured in minutes

    Time frame: Up to 3 hours

    Length of surgery measured in minutes

  5. Number of postoperative complications

    Time frame: Up to 90 days

    Number of postoperative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Victor H Hernandez, MD

CONTACT

[email protected]

305-689-5195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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