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NCT Number: NCT07237737

Alexis Retractor in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alexis wound retractor

Device

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

Standard wound retractor

Device

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

Primary outcomes

  1. Number of Days to Identification of Delayed Wound Healing

    Time frame: Up to 14 days

    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

  2. Patient satisfaction with scaring as measured by Patient Scar Assessment Scale

    Time frame: Up to 12 months

    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.

  3. Scar cosmesis as measured by Observer Scar Assessment Scale

    Time frame: Up to 12 months

    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.

Secondary outcomes

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

    Time frame: Up to 6 months

    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.

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

    Time frame: Up to 12 months

    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.

  3. Number of Intraoperative fractures

    Time frame: Up to 3 hours (duration of surgery)

    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.

  4. Length of surgery

    Time frame: Up to 3 hours

    Duration of the surgical procedure measured in minutes, from initial incision to closure.

  5. Number of Postoperative Complications

    Time frame: Up to 90 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Cruz, MD

CONTACT

[email protected]

305-689-5195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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