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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
A conventional surgical retractor used during procedures without the features of the Alexis device
University of Miami
Miami, Florida, United States
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
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
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.
Time frame: 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.
Time frame: Up to 12 months
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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.
Time frame: Up to 3 hours (duration of surgery)
Length of surgery
Duration of the surgical procedure measured in minutes, from initial incision to closure.
Time frame: 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.
Time frame: Up to 90 days