Hip Arthritis, Hip Osteoarthritis
Conditions
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.
Interventions
DEVICEAlexis wound retractor
A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
DEVICEStandard wound retractor
A conventional surgical retractor used during procedures without the features of the Alexis device
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Identification of Delayed Wound Healing | 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 |
| Patient satisfaction with scaring as measured by Patient Scar Assessment Scale | 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. |
| Scar cosmesis as measured by Observer Scar Assessment Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms | 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. |
| Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome | 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. |
| Number of Intraoperative fractures | 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. |
| Length of surgery | Up to 3 hours | Duration of the surgical procedure measured in minutes, from initial incision to closure. |
| Number of Postoperative Complications | 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. |
Countries
United States
Contacts
CONTACTNatalia Cruz, MD
PRINCIPAL_INVESTIGATORVictor H Hernandez, MD, MSc
University of Miami Department of Orthopaedics
Outcome results
None listed