Alexis Retractor for Hip Arthritis

Overseen By Natalia Cruz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Prior hip surgery, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using the Alexis wound retractor (a surgical tool) during hip replacement surgery improves wound healing and reduces infection risk. Participants will undergo surgery with either the Alexis retractor or a standard tool. The trial targets individuals receiving their first hip replacement through a specific front-side approach. Those with previous hip surgeries on either hip or specific drug allergies are not eligible. This research could enhance recovery experiences for future hip surgery patients. As an unphased trial, it offers participants the chance to contribute to advancements in surgical techniques that may improve recovery for future patients.

What prior data suggests that the Alexis Retractor is safe for hip arthroplasty?

Research has shown that the Alexis retractor is generally safe for surgeries like hip replacements. Studies have found that it not only protects the surgical area but also helps prevent thick scars, indicating it is well-tolerated during surgery.

While specific data on problems related to the Alexis retractor is lacking, its use in surgeries suggests safety. Surgeons often choose it because it can help wounds heal better, signaling its reliability and safety in surgical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically uses standard retractors during hip surgeries, the Alexis Retractor is unique because it offers a novel approach to maintaining a clear surgical field. Researchers are excited about this device because it provides 360-degree access and protection to the surgical site, potentially reducing tissue trauma and improving healing times. This retractor could lead to more efficient surgeries and better postoperative outcomes for patients with hip arthritis.

What evidence suggests that the Alexis Retractor is effective for hip arthritis?

Studies have shown that the Alexis retractor, which participants in this trial may receive, can improve wound healing during hip replacement surgeries. Research indicates that this device protects the wound and lowers the risk of hypertrophic scarring. Another study found that this retractor might help prevent infections at the surgical site. Initial findings suggest that this tool reduces damage to wound edges, resulting in better-looking scars. Overall, evidence supports the effectiveness of the Alexis retractor in enhancing outcomes after hip surgery. Participants in the other arm of this trial will undergo surgery using a standard retractor without the Alexis device. ^{2 3 6 7 8}

Who Is on the Research Team?

Victor H Hernandez, MD, MSc

Principal Investigator

University of Miami Department of Orthopaedics

Are You a Good Fit for This Trial?

This trial is for patients who are having their first total hip replacement through a direct anterior approach. It's not for those who've had previous open surgery on the same hip or a hip replacement on the other side, nor for people allergic to drugs used in the University of Miami's standard hip replacement protocol.

Inclusion Criteria

I am scheduled for my first total hip replacement surgery.

I am having a hip replacement through the front of my hip.

Exclusion Criteria

I have had open surgery on my hip before.

I have had a total hip replacement on the opposite side.

I am allergic or cannot take certain drugs used in the University of Miami's hip replacement protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total hip arthroplasty using either the Alexis wound retractor or a standard retractor

Up to 3 hours

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for delayed wound healing and postoperative complications

Up to 14 days

Multiple visits (in-person)

Follow-up

Participants are monitored for long-term outcomes including scar assessment and hip function

Up to 12 months

Regular visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Alexis Retractor

Trial Overview The study is comparing wound healing and infection rates between two groups: one using the Alexis wound retractor and another using a standard retractor during direct anterior approach total hip arthroplasty.

How Is the Trial Designed?

Group I: Alexis Retractor Experimental Treatment 1 Intervention

Subjects in this arm will undergo surgery using the Alexis wound retractor.

Group II: Non-Alexis Retractor Active Control 1 Intervention

Subjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289496/

Alexis® Orthopedic Protector Provides Wound Protection ... Alexis Orthopedic Protectors can not only provide short-term wound protection but also reduce the rate and degree of hypertrophic scarring.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38193610/

The advantages of a single use retractor for soft tissue ... We believe that the adoption of the Alexis Orthopedic Protector provides numerous improvements during the hip arthroplasty surgical procedure.

3. researchgate.net researchgate.net/publication/382765709_AlexisR_Orthopedic_Protector_Provides_Wound_Protection_and_Aids_in_Hypertrophic_Scar_Prevention_in_Total_Hip_Arthroplasty

(PDF) Alexis® Orthopedic Protector Provides Wound ... Alexis® Orthopedic Protector Provides Wound Protection and Aids in Hypertrophic Scar Prevention in Total Hip Arthroplasty ; Shuro Furuichi.

4. blogs.the-hospitalist.org blogs.the-hospitalist.org/content/evaluation-wound-healing-after-direct-anterior-total-hip-arthroplasty-use-novel-retraction

Evaluation of Wound Healing After Direct Anterior Total Hip ... Day-of-surgery data ... Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites.

5. cdn.mdedge.com cdn.mdedge.com/files/s3fs-public/issues/articles/ajo04401e017.pdf

Evaluation of Wound Healing After Direct Anterior Total Hip ... We prospectively investigated whether a specialized ring retractor was effective in minimizing wound-edge trauma, as evidenced by improved scar cosmesis. Fifty.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07237737

Alexis Retractor in 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 ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7147317&pc=GAD

RING (WOUND PROTECTOR), DRAPE RETENTION ... Action plan: the surgeon will monitor continued use of the alexis wound protector/retractor ref (b)(4) for hip replacement procedures.The surgeon prefers this ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39086781/

Alexis® Orthopedic Protector Provides Wound Protection ... Alexis® Orthopedic Protectors can not only provide short-term wound protection but also reduce the rate and degree of hypertrophic scarring.