Alexis Retractor in Total Hip Arthroplasty

University of Miami

Status: Begins enrollment in 9 months

Conditions: Hip Osteoarthritis; Hip Arthritis

Treatments: Device: Standard wound retractor; Device: Alexis wound retractor

Study type: Interventional

Funder types: Other

Identifiers

NCT07237737

20251013

Details and patient eligibility

About

To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty.

Enrollment: 202 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
• Patients undergoing primary total hip arthroplasty

Exclusion criteria

• Patients with history of prior open surgery on the affected hip
• Patients with history of prior total hip arthroplasty on the contralateral hip
• Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Alexis Retractor

Experimental group

Description:

Subjects in this arm will undergo surgery using the Alexis wound retractor.

Treatment:

Device: Alexis wound retractor

Non-Alexis Retractor

Active Comparator group

Description:

Subjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device.

Treatment:

Device: Standard wound retractor