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COMPLETED
NCT07621250
NA

Alexis O-Ring and Charnley Retrievers and Its Effect on Contamination on Total Hip Arthroplasty

Sponsor: Hospital del Mar

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2024-04-20

Completion Date

2026-03-10

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DEVICE

Alexis O-Ring Wound Retractor

Circular polyurethane wound retractor (Applied Medical, Rancho Santa Margarita, CA, USA). A rigid deep ring is placed beneath the fascia lata, and the polyurethane cylinder is rolled around the outer ring to retract wound edges and create a physical barrier between the skin and the surgical field.

DEVICE

Charnley Retractor

Semi-rigid stainless steel ortostatic retractor consisting of a bow with two blades (one fixed, one adjustable). Placed around the incision at the level of the fascia lata to retract wound edges through elastic tension. Standard retractor currently used in total hip arthroplasty.

Locations (1)

Hospital del Mar

Barcelona, Spain