- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06006572
Hip DAA Closure Techniques
August 17, 2023 updated by: Rothman Institute Orthopaedics
Direct Anterior Approach of the Hip and Variations in Wound Complications Using Different Closure Techniques
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.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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
|
Active Comparator: 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
|
wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound complications
Time Frame: 90 days
|
Assessed using photographic documentation of the wound
|
90 days
|
Participant satisfaction
Time Frame: 90 days
|
assessed using the POSAS (patient and observer scar assessment scale) questionnaire
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
October 30, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
August 17, 2023
First Submitted That Met QC Criteria
August 17, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Actual)
August 23, 2023
Last Update Submitted That Met QC Criteria
August 17, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CKRU2023-1674
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Total Hip Replacement
-
National Taiwan University HospitalUnknownTotal Hip Replacement | Total Hip ArthroplastyTaiwan
-
The Royal Bournemouth HospitalCompletedArthroplasty, Replacement, Hip | Hip Replacement, TotalUnited Kingdom
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical AssociationCompletedTotal Hip Replacement | Total Knee ReplacementCanada
-
Ortho Development CorporationOregon Health and Science UniversityEnrolling by invitationTotal Hip Replacement | Total Hip ArthroplastyUnited States
-
Mayo ClinicCompletedKnee Total Joint Replacement | Hip Total Joint ReplacementUnited States
-
Musgrave Park HospitalBelfast Health and Social Care Trust; Queen's University, Belfast; Belfast Arthroplasty...CompletedTotal Hip Replacement | Total Hip Arthroplasty | THA | THRUnited Kingdom
-
Koneksa HealthRecruitingTotal Hip ReplacementUnited States
-
Second Hospital of Shanxi Medical UniversityRecruitingTotal Hip ReplacementChina
-
Medacta International SASuspended
-
EgymedicalpediaOctober 6 UniversityCompletedTotal Hip ReplacementEgypt