Hip OsteoarthritisNCT07237737
Alexis Retractor in Total Hip Arthroplasty
A study testing Alexis wound retractor and Standard wound retractor in people with Hip Osteoarthritis and Hip Arthritis, run by University of Miami at 1 site in United States.
Trial summary
To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthritis
- What is being tested?
- Alexis wound retractor and Standard wound retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
- Patients undergoing primary total hip arthroplasty
Who cannot join
- Patients with history of prior open surgery on the affected hip
- Patients with history of prior total hip arthroplasty on the contralateral hip
- Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33125
Natalia Cruz, MD, 3056895195, nxc971@miami.edu
About this study
Official title: Wound Healing Outcomes With and Without the Alexis Wound Retractor in Direct Anterior Approach Total Hip Arthroplasty
To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty.
- Conditions
- Hip Osteoarthritis, Hip Arthritis
- Being tested
- Alexis wound retractor, Standard wound retractor
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexis wound retractorDevice
A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing
Standard wound retractorDevice
A conventional surgical retractor used during procedures without the features of the Alexis device
| Study group | Role | What they receive |
|---|---|---|
| Alexis Retractor | Experimental | Subjects in this arm will undergo surgery using the Alexis wound retractor. Receives: Device: Alexis wound retractor |
| Non-Alexis Retractor | Active comparator | Subjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device. Receives: Device: Standard wound retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days to Identification of Delayed Wound Healing
Delayed wound healing is defined as the presence of one or more of the following clinical signs: drainage from wound, wound dehiscence, and superficial surgical site infection. Assessment is performed by clinical examination and documentation in the postoperative period. The outcome is measured in number of days from surgery to identification of delayed healing
Measured: Up to 14 days
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
Using the Patient Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the patient's perspective. Measured with a scale from 0 to 10, higher score indicates less satisfaction.
Measured: Up to 12 months
Scar cosmesis as measured by Observer Scar Assessment Scale
Using the Observer Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the observer perspective. Measured with a scale from 0 to 10, higher score indicates worse scar cosmesis.
Measured: Up to 12 months
Secondary outcomes (5)
Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms
LFCN symptoms are defined as paresthesias or dysesthesias in the anterior thigh distal to the surgical site. Symptoms are assessed through participant self-report and clinical documentation.
Measured: Up to 6 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome
Assessed using the HOOS, a validated instrument for evaluating hip-related disability and osteoarthritis symptoms from the patient's perspective. Scores range from 0 to 28, with higher scores indicating worse patient-reported outcomes.
Measured: Up to 12 months
Number of Intraoperative fractures
Intraoperative complications will be assessed by counting the number of fractures occurring during the surgical procedure; fractures are identified by the operating surgeon and confirmed via intraoperative imaging or direct visualization.
Measured: Up to 3 hours (duration of surgery)
Length of surgery
Duration of the surgical procedure measured in minutes, from initial incision to closure.
Measured: Up to 3 hours
Number of Postoperative Complications
Measured by the number of complications including, but not limited to, periprosthetic joint infection (PJI), prosthetic hip dislocation, periprosthetic fracture, implant failure requiring revision surgery. Events are identified through clinical evaluation and documentation.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study startDec 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Hugo Hernandez, University of Miami
- Investigators
- Victor H Hernandez, MD, MSc, Principal investigator, University of Miami Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237737
- Sponsor's protocol ID
- 20251013
- Status last verified
- Feb 2026
- First submitted
- 15 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing Outcomes With and Without the Alexis Wound Retractor in Direct Anterior Approach Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07237737
- Acronym / sponsor ID
- 20251013
- Conditions
- Hip Osteoarthritis, Hip Arthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Nov 2025 (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.
To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alexis Retractor | Experimental | Device: Alexis wound retractorSubjects in this arm will undergo surgery using the Alexis wound retractor. |
| Non-Alexis Retractor | Active comparator | Device: Standard wound retractorSubjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
- Patients undergoing primary total hip arthroplasty
Key exclusion criteria (3 listed)
- Patients with history of prior open surgery on the affected hip
- Patients with history of prior total hip arthroplasty on the contralateral hip
- Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
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 wound retractorA surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing | Device | Alexis Retractor |
| Standard wound retractorA conventional surgical retractor used during procedures without the features of the Alexis device | Device | Non-Alexis Retractor |
Primary outcome
Number of Days to Identification of Delayed Wound Healing
Time frame: Up to 14 days
Delayed wound healing is defined as the presence of one or more of the following clinical signs: drainage from wound, wound dehiscence, and superficial surgical site infection. Assessment is performed by clinical examination and documentation in the postoperative period. The outcome is measured in number of days from surgery to identification of delayed healing
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
Time frame: Up to 12 months
Using the Patient Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the patient's perspective. Measured with a scale from 0 to 10, higher score indicates less satisfaction.
Scar cosmesis as measured by Observer Scar Assessment Scale
Time frame: Up to 12 months
Using the Observer Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the observer perspective. Measured with a scale from 0 to 10, higher score indicates worse scar cosmesis.
5 secondary outcomes
Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms
Time frame: Up to 6 months
Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome
Time frame: Up to 12 months
Number of Intraoperative fractures
Time frame: Up to 3 hours (duration of surgery)
Length of surgery
Time frame: Up to 3 hours
Number of Postoperative Complications
Time frame: Up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Victor H Hernandez, MD, MSc principal investigator
University of Miami Department of Orthopaedics
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 wound retractor and Standard wound retractor in people with Hip Osteoarthritis and Hip Arthritis, run by University of Miami at 1 site in United States.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Feb 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Cruz, MD (305-689-5195, nxc971@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days to Identification of Delayed Wound Healing (time frame: Up to 14 days). The study lists 3 primary outcomes in all. 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 5 Feb 2026.