Alexis Retractor in Total Hip Arthroplasty

NCT07237737 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 20251013
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis; Hip Arthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms

  Up to 6 months

• Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome

  Up to 12 months

• Number of Intraoperative fractures

  Up to 3 hours (duration of surgery)

• Length of surgery

  Up to 3 hours

• Number of Postoperative Complications

  Up to 90 days

Study Arms (2)

Alexis Retractor

EXPERIMENTAL

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

Device: Alexis wound retractor

Non-Alexis Retractor

ACTIVE COMPARATOR

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

Device: Standard wound retractor

Interventions

Standard wound retractor DEVICE

A conventional surgical retractor used during procedures without the features of the Alexis device

Non-Alexis Retractor

Alexis wound retractor DEVICE

A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing

Alexis Retractor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Victor H Hernandez, MD, MSc

  University of Miami Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Cruz, MD

CONTACT

305-689-5195; nxc971@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)