Hip DAA Closure Techniques

NCT ID: NCT06006572

Last Updated: 2023-08-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-30

Brief Summary

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This study aims to analyze the difference in rates of wound complications using two different closure techniques in Direct anterior approach for primary total hip replacement.

Detailed Description

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The use of the direct anterior approach (DAA) for primary total hip arthroplasty (THA) has been increasingly popular but there has been a reported increased risk of wound complications compared with a posterior approach. Wound complications can lead to increased length of stay, reoperation procedures (i.e., irrigation and debridement), patient dissatisfaction, extra visits, readmissions, increased risk of periprosthetic joint infection and overall increased costs.

Conditions

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Total Hip Replacement Wound Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

Group Type ACTIVE_COMPARATOR

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

Intervention Type PROCEDURE

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Group Type ACTIVE_COMPARATOR

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Intervention Type PROCEDURE

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Interventions

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wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive

Intervention Type PROCEDURE

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients older than 18 years old that will undergo THA via DAA

Exclusion Criteria

* Previous hip arthroplasty surgeries or scars
* THA secondary to oncologic or traumatic etiologies
* BMI ≥ 40
* uncontrolled diabetes (measured by a Hgb A1c above 8)
* reported allergy to skin adhesive
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CKRU2023-1674

Identifier Type: -

Identifier Source: org_study_id

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