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

University of Miami110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

THA

Interventions

Bikini IncisionPROCEDURE

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 IncisionPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Time frame: Up to 6 months

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

Number of intraoperative fractures

Time frame: Up to 3 hours

Length of surgery measured in minutes

Time frame: Up to 3 hours

Number of postoperative complications

Central Contacts

Victor H Hernandez, MD

CONTACT

305-689-5195 vhh1@miami.edu

Data from ClinicalTrials.gov

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