Total Hip Arthroplasty (THA)NCT07621250
Alexis O-Ring and Charnley Retrievers and Its Effect on Contamination on Total Hip Arthroplasty
A study testing Alexis O-Ring Wound Retractor and Charnley Retractor in people with Total Hip Arthroplasty (THA), run by Hospital del Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Alexis O-Ring Wound Retractor and Charnley Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2024to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with symptomatic hip osteoarthritis indicated for primary total hip arthroplasty (THA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alexis O-Ring and Charnley Retrievers in Total Hip Arthroplasty Surgery. Is There Any Difference in Intraoperative Contamination Rates?
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)
- Being tested
- Alexis O-Ring Wound Retractor, Charnley Retractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexis O-Ring Wound RetractorDevice
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.
Charnley RetractorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Alexis O-Ring retractor | Experimental | Not described Receives: Device: Alexis O-Ring Wound Retractor |
| Charnley retractor | Active comparator | Not described Receives: Device: Charnley Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start20 Apr 2024
- Primary completion24 May 2025
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621250
- Sponsor's protocol ID
- CHA-ALE_THR
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing plan is foreseen for this study
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alexis O-Ring and Charnley Retrievers in Total Hip Arthroplasty Surgery. Is There Any Difference in Intraoperative Contamination Rates?
- ClinicalTrials.gov ID
- NCT07621250
- Acronym / sponsor ID
- CHA-ALE_THR
- Conditions
- Total Hip Arthroplasty (THA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 24 May 2025 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alexis O-Ring retractor | Experimental | Device: Alexis O-Ring Wound Retractor |
| Charnley retractor | Active comparator | Device: Charnley Retractor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with symptomatic hip osteoarthritis indicated for primary total hip arthroplasty (THA)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alexis O-Ring Wound RetractorCircular 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 | Alexis O-Ring retractor |
| Charnley RetractorSemi-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. | Device | Charnley retractor |
Primary outcome
Surgical site contamination rate
Time frame: Intraoperative
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing plan is foreseen for this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alexis O-Ring Wound Retractor and Charnley Retractor in people with Total Hip Arthroplasty (THA), run by Hospital del Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site contamination rate (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.