Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06831045

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionTHA

Full registry criteria

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.

Treatments and study arms

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

Wound Healing measured in number of daysUp 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 ScaleUp to to 6 months

Score ranges from 0 to 10. Higher scores indicate less satisfaction

Scar cosmesis as measured by Observer Scar Assessment ScaleUp to 6 months

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Miami🇺🇸 Miami, Florida, United States
Jonathan M Stern, MDContact
Natalia Cruz-Ossa, MDContact
Victor H Hernandez, MDPrincipal Investigator