Health TrialsbyHealthPanel

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

ConditionTHA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with body mass index greater than or equal to 30

Patients undergoing primary unilateral DAA THA

Patients undergoing primary THA

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bikini Incision

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Bikini Incision GroupExperimental treatment 1 intervention
Group B: Longitudinal Incision GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Wound Healing measured in number of days

Will be measured in number of days the incision will take to heal.

Time frame
Up to 14 days
2

Patient satisfaction with scaring as measured by Patient Scar Assessment Scale

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

Time frame
Up to to 6 months
3

Scar cosmesis as measured by Observer Scar Assessment Scale

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

Time frame
Up to 6 months

Secondary outcomes

1

Number of participants who report lateral femoral cutaneous nerve-related symptoms

Number of participants who report lateral femoral cutaneous nerve-related symptoms

Time frame
Up to 6 months
2

Patient reported outcomes as measured by Hip Disability and Osteoarthritis Outcomes

Scores range from 0 to 28. Higher scores indicate worse patient reported outcomes

Time frame
Up to 6 months
3

Number of intraoperative fractures

Number of intraoperative fractures

Time frame
Up to 3 hours
4

Length of surgery measured in minutes

Length of surgery measured in minutes

Time frame
Up to 3 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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