Alexis Retractor in Total Hip Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
Patients undergoing primary total hip arthroplasty
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Alexis wound retractor
DeviceA surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
Standard wound retractor
DeviceA conventional surgical retractor used during procedures without the features of the Alexis device
Treatment groups
202 Participants
are divided into 2 treatment groupsGroup A: Alexis RetractorExperimental treatment 1 intervention
Group B: Non-Alexis RetractorActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
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 months3
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 monthsSecondary outcomes
1
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 months2
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 months3
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)4
Length of surgery
Duration of the surgical procedure measured in minutes, from initial incision to closure.
Time frame
Up to 3 hoursSponsors and contacts
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Source ClinicalTrials.gov
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