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NCT06006572 Clinical Trial

Hip DAA Closure Techniques

Total Hip Replacement Clinical Trial

Official title:
Direct Anterior Approach of the Hip and Variations in Wound Complications Using Different Closure Techniques

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06006572
Other study ID # CKRU2023-1674
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date October 30, 2024

Study information
Verified date August 2023
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 172
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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
• 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

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound complications Assessed using photographic documentation of the wound 90 days
Primary Participant satisfaction assessed using the POSAS (patient and observer scar assessment scale) questionnaire 90 days
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