Alexis Retractor in Total Hip Arthroplasty

Wound Healing Outcomes With and Without the Alexis Wound Retractor in Direct Anterior Approach Total Hip Arthroplasty

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Osteoarthritis; Hip Arthritis
• Intervention / Treatment: Device: Alexis wound retractor; Device: Standard wound retractor

• Study Type: Interventional
• Enrollment (Estimated): 202
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Cruz, MD; Phone Number: 305-689-5195; Email: nxc971@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami
      • Contact: Natalia Cruz, MD; Phone Number: 3056895195; Email: nxc971@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alexis Retractor; Subjects in this arm will undergo surgery using the Alexis wound retractor.	Device: Alexis wound retractor; A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
Active Comparator: Non-Alexis Retractor; Subjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device.	Device: Standard wound retractor; A conventional surgical retractor used during procedures without the features of the Alexis device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days to Identification of Delayed Wound Healing	Delayed wound healing is defined as the presence of one or more of the following clinical signs: drainage from wound, wound dehiscence, and superficial surgical site infection. Assessment is performed by clinical examination and documentation in the postoperative period. The outcome is measured in number of days from surgery to identification of delayed healing	Up to 14 days
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale	Using the Patient Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the patient's perspective. Measured with a scale from 0 to 10, higher score indicates less satisfaction.	Up to 12 months
Scar cosmesis as measured by Observer Scar Assessment Scale	Using the Observer Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the observer perspective. Measured with a scale from 0 to 10, higher score indicates worse scar cosmesis.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms	LFCN symptoms are defined as paresthesias or dysesthesias in the anterior thigh distal to the surgical site. Symptoms are assessed through participant self-report and clinical documentation.	Up to 6 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome	Assessed using the HOOS, a validated instrument for evaluating hip-related disability and osteoarthritis symptoms from the patient's perspective. Scores range from 0 to 28, with higher scores indicating worse patient-reported outcomes.	Up to 12 months
Number of Intraoperative fractures	Intraoperative complications will be assessed by counting the number of fractures occurring during the surgical procedure; fractures are identified by the operating surgeon and confirmed via intraoperative imaging or direct visualization.	Up to 3 hours (duration of surgery)
Length of surgery	Duration of the surgical procedure measured in minutes, from initial incision to closure.	Up to 3 hours
Number of Postoperative Complications	Measured by the number of complications including, but not limited to, periprosthetic joint infection (PJI), prosthetic hip dislocation, periprosthetic fracture, implant failure requiring revision surgery. Events are identified through clinical evaluation and documentation.	Up to 90 days

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Victor H Hernandez, MD, MSc, University of Miami Department of Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 15, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 20251013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes