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

NCT07621250 | Completed

• 1 other identifier: CHA-ALE_THR
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (1)

• Surgical site contamination rate

  Intraoperative surgical site contamination assessed through four standardized cultures: (1) subcutaneous tissue immediately after incision, (2) deep tissue (joint capsule) before arthrotomy, (3) deep tissue after placement of definitive prosthetic components, and (4) subcutaneous tissue after retractor removal.

  Intraoperative

Study Arms (2)

Alexis O-Ring retractor

EXPERIMENTAL

Device: Alexis O-Ring Wound Retractor

Charnley retractor

ACTIVE COMPARATOR

Device: Charnley Retractor

Interventions

Alexis O-Ring Wound Retractor DEVICE

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.

Alexis O-Ring retractor

Charnley Retractor DEVICE

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.

Charnley retractor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08024, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: April 20, 2024
• Primary Completion: May 24, 2025
• Study Completion: March 10, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)