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Clinical Trials/NCT07621250
NCT07621250CompletedNot Applicable

Alexis O-Ring and Charnley Retrievers in Total Hip Arthroplasty Surgery. Is There Any Difference in Intraoperative Contamination Rates?

Hospital del Mar1 site in 1 country144 target enrollmentStarted: April 20, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
144
Locations
1

Study Overview

Brief Summary

Randomized, prospective, single-blind clinical trial comparing two static wound retractors - the Charnley retractor and the Alexis O-Ring retractor - in primary total hip arthroplasty (THA). The primary objective is to compare surgical site contamination rates between the two devices. Secondary objectives include comparison of incision length, surgical time, intraoperative skin lesions, and postoperative complications including periprosthetic joint infection. Patients will be randomized 1:1 to either retractor group. Surgical site contamination will be assessed through four intraoperative cultures taken at standardized timepoints. Follow-up will be conducted at 1 month postoperatively.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients diagnosed with symptomatic hip osteoarthritis indicated for primary total hip arthroplasty (THA)

Exclusion Criteria

  • Previous surgical interventions or scar tissue over the hip to be operated Subcapital femoral fractures requiring THA (non-primary indication) History of infection in any previous joint arthroplasty procedure Immunological disorders increasing the risk of periprosthetic joint infection (diagnosed immunodeficiencies, chemotherapy or immunosuppressive treatment) Advanced dementia or severe cognitive impairment precluding informed consent

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carlos Torrens

PhD

Hospital del Mar

Study Sites (1)

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