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Not yet recruiting NCT07237737

Alexis Retractor in Total Hip Arthroplasty

No phase Interventional Hip Osteoarthritis Hip Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alexis wound retractor, Standard wound retractor.
Who it may be relevant to
Registry conditions: Hip Osteoarthritis, Hip Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device Alexis wound retractor
    A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
  • Device Standard wound retractor
    A conventional surgical retractor used during procedures without the features of the Alexis device

Primary outcome measures

  • Number of Days to Identification of Delayed Wound Healing [Time frame: Up to 14 days]
  • Patient satisfaction with scaring as measured by Patient Scar Assessment Scale [Time frame: Up to 12 months]
  • Scar cosmesis as measured by Observer Scar Assessment Scale [Time frame: Up to 12 months]
Secondary outcome measures (5)
  • Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms [Time frame: Up to 6 months]
  • Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome [Time frame: Up to 12 months]
  • Number of Intraoperative fractures [Time frame: Up to 3 hours (duration of surgery)]
  • Length of surgery [Time frame: Up to 3 hours]
  • Number of Postoperative Complications [Time frame: Up to 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT07237737 · 20251013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗