Knotless Suture in Revision Total Joint Arthroplasty

Study Overview
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Brief Summary
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Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.

Official Title
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Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

Conditions
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Arthroplasty

Intervention / Treatment
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* Device: Conventional Closure: Knee
* Device: Barbed suture closure: Knee
* Device: Conventional Closure: Hip
* Device: Barbed suture closure: Hip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age 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: Patient is ≤ 18 years of age Patient is unable to provide written consent Patient has active infections in the operative leg/joint Known Allergy to Suture material 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 Anterior total hip replacement Stage 1 of two stage revision for infection Closure performed by plastic surgeon, including flap coverage Vulnerable populations will not be enrolled in this study. Withdrawal Criteria Failure to attend regularly scheduled follow up appointments Deviation from closure protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, controlled trial, parallel four-arm design, single-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Revision total knee arthroplasty: control<br> | Device: Conventional Closure: Knee<br>* 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.<br>|
| Experimental: Revision total knee arthroplasty: active<br> | Device: Barbed suture closure: Knee<br>* 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.<br>|
| Active Comparator: Revision Total Hip Arthroplasty: control<br> | Device: Conventional Closure: Hip<br>* The capsule will be closed with Vicryl Plus number 1 Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson).<br>|
| Experimental: Revision Total Hip Arthroplasty: active<br> | Device: Barbed suture closure: Hip<br>* The capsule will be closed with stratafix symmetric PDS Plus Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) Subcuticular suture with stratafix spiral monocryl plus, Ethicon followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of closure in seconds | Measurement of the time needed to properly close the wound with each technique. | 30 minutes (perioperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Complications Related to Wound Closure | Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure. | Day 90 | 
| Total Cost of Assigned Closure Procedure | Assessment of the cost difference based on supplies, personnel, and time between each technique. | Day 90 | 
| Patient and Observer Scar Assessment Scale (POSAS) Score | The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars. | Week 6 Post-Surgery | 
| Total Number of Sutures Used |  | 30 minutes (perioperative) | 
| Length of Incision |  | 30 minutes (perioperative) |