Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2020-09-01
2023-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Revision total knee arthroplasty: control
Conventional Closure: Knee
Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
Revision total knee arthroplasty: active
Barbed suture closure: Knee
The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
Revision Total Hip Arthroplasty: control
Conventional Closure: Hip
1. The capsule will be closed with Vicryl Plus number 1
2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)
4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson)
5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
Revision Total Hip Arthroplasty: active
Barbed suture closure: Hip
1. The capsule will be closed with stratafix symmetric PDS Plus
2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ)
4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon
5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
Interventions
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Conventional Closure: Knee
Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
Barbed suture closure: Knee
The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
Conventional Closure: Hip
1. The capsule will be closed with Vicryl Plus number 1
2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)
4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson)
5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
Barbed suture closure: Hip
1. The capsule will be closed with stratafix symmetric PDS Plus
2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ)
4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon
5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
Eligibility Criteria
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Inclusion Criteria
2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture
Exclusion Criteria
2. Patient is unable to provide written consent
3. Patient has active infections in the operative leg/joint
4. Known Allergy to Suture material
5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population
6. Anterior total hip replacement
7. Stage 1 of two stage revision for infection
8. Closure performed by plastic surgeon, including flap coverage
Vulnerable populations will not be enrolled in this study.
Withdrawal Criteria
1. Failure to attend regularly scheduled follow up appointments
2. Deviation from closure protocol
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ran Schwarzkopf, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-00280
Identifier Type: -
Identifier Source: org_study_id
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