Alexis Retractor in Total Hip Arthroplasty

NCT ID: NCT07237737

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Osteoarthritis Hip Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alexis Retractor

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

Group Type EXPERIMENTAL

Alexis wound retractor

Intervention Type DEVICE

A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing

Non-Alexis Retractor

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

Group Type ACTIVE_COMPARATOR

Standard wound retractor

Intervention Type DEVICE

A conventional surgical retractor used during procedures without the features of the Alexis device

Interventions

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Alexis wound retractor

A surgical device used to retract tissue during procedures, designed to reduce wound trauma and improve healing

Intervention Type DEVICE

Standard wound retractor

A conventional surgical retractor used during procedures without the features of the Alexis device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
* Patients undergoing primary total hip arthroplasty

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Victor Hugo Hernandez

Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor H Hernandez, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Miami Department of Orthopaedics

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Natalia Cruz, MD

Role: CONTACT

305-689-5195

Facility Contacts

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Natalia Cruz, MD

Role: primary

3056895195

Other Identifiers

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20251013

Identifier Type: -

Identifier Source: org_study_id

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