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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alexis Retractor | Experimental | Subjects in this arm will undergo surgery using the 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alexis wound retractor | Device | A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalia Cruz, MD | Contact | 305-689-5195 | nxc971@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Victor H Hernandez, MD, MSc | University of Miami Department of Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33125 | United States |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Standard wound retractor | Device | A conventional surgical retractor used during procedures without the features of the Alexis device |
|
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 |
| D012216 |
| Rheumatic Diseases |