Symmetric on Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty (TKA)

Detailed Description
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The primary objective of this prospective, randomized controlled study is to evaluate the wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined as the total time required to close the surgical incisions in patients undergoing TKA procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures. Secondary objectives will include the evaluation of differences in overall surgical procedure time, operating room (OR) time, length of stay, procedure costs, quality of life measures including pain, and range of motion (ROM). In addition, the difference in the safety profiles for both wound closure procedures will be evaluated through the analysis of the incidence of wound complications including dehiscence, wound infections, and other adverse events.

Official Title
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A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)

Conditions
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Wound Closure

Intervention / Treatment
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* Device: STRATAFIX™ Symmetric Knotless Tissue
* Device: VICRYL® PLUS
* Device: STRATAFIX Spiral sutures
* Device: DERMABOND™ Advance™ Skin Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 years and < 80 years of age; Patient with osteoarthritis is scheduled to undergo elective unilateral TKA; Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete. Exclusion Criteria: Female patient who is pregnant or lactating at the time of screening; Patient has a Body Mass Index (BMI) > 40 kg/m2; Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid); Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology; Patient has had previous open surgeries on the affected joint other than arthroscopy; Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing; Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®* MP) or D&C Violet No. 2; Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0 mmol/L; Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months; Patient has undergone chemotherapy or radiation within the last 6 months prior to study enrollment or is scheduled to do so during the study period; Patient has known personal or family history of keloid formation or hypertrophy; Patient has other dermatologic conditions known to impair wound healing; Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; Patient has any physical or psychological condition which would impair study participation; and Patient is judged unsuitable for study participation by the investigator for any other reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barbed suture group<br>The deep layer and the intermediate layer will be repaired and closed by using one STRATAFIX™ Symmetric Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. | Device: STRATAFIX™ Symmetric Knotless Tissue<br>* This devices will be used in deep and intermediate layers of barbed suture group.<br>* Other names: STRATAFIX Symmetric;Device: STRATAFIX Spiral sutures<br>* This devices will be used in intradermal layer of both barbed suture and conventional suture group.<br>* Other names: Spiral;Device: DERMABOND™ Advance™ Skin Closure System<br>* This devices will be used in skin layer of both barbed suture and conventional suture group.<br>* Other names: DERMABOND;|
| Active Comparator: Conventional suture group<br>VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation. | Device: VICRYL® PLUS<br>* This devices will be used in deep and intermediate layers of conventional suture group.<br>* Other names: Polyglactin 910;Device: STRATAFIX Spiral sutures<br>* This devices will be used in intradermal layer of both barbed suture and conventional suture group.<br>* Other names: Spiral;Device: DERMABOND™ Advance™ Skin Closure System<br>* This devices will be used in skin layer of both barbed suture and conventional suture group.<br>* Other names: DERMABOND;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suturing Time | The total time required to close the surgical incisions between treatment groups. | During Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TKA, Barbed suture, Surgical time