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CompletedNCT07621250Updated Jun 2, 2026

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

An interventional study of Alexis O-Ring Wound Retractor and Charnley Retractor in Total Hip Arthroplasty (THA), sponsored by Hospital del Mar. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Hospital del Mar · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Apr 2024, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Total Hip Arthroplasty (THA)
03

In context

Lead sponsor

Hospital del Mar is the lead sponsor of 45 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    Alexis O-Ring retractor

    Device: Alexis O-Ring Wound Retractor

  • Active comparator
    Charnley retractor

    Device: Charnley Retractor

Interventions

  • DeviceAlexis 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.

  • DeviceCharnley 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.

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What researchers measure

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.

    Time frame: Intraoperative

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Study locations

1 site
  • Hospital del Mar
    Barcelona, 08024, Spain
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References and documents

Individual participant data

Plan to share: No — No individual participant data sharing plan is foreseen for this study

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07621250
Lead sponsor
Hospital del Mar
Responsible party
Carlos Torrens (PhD, Hospital del Mar) — Principal investigator
First posted
Jun 2, 2026
Start date
Apr 20, 2024
Primary completion
May 24, 2025
Completion
Mar 10, 2026
Last update
Jun 2, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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