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

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University of Miami

Status

Enrolling

Conditions

THA

Treatments

Procedure: Longitudinal Incision
Procedure: Bikini Incision

Study type

Interventional

Funder types

Other

Identifiers

NCT06831045
20230334

Details and patient eligibility

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Bikini Incision Group
Experimental group
Description:
Participants in this group will receive the bikini incision during THA. Total participation is up to 90 days.
Treatment:
Procedure: Bikini Incision
Longitudinal Incision Group
Experimental group
Description:
Participants in this group will receive the longitudinal incision during THA. Total participation is up to 90 days.
Treatment:
Procedure: Longitudinal Incision

Trial contacts and locations

1

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Central trial contact

Victor H Hernandez, MD

Data sourced from clinicaltrials.gov

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