Symmetric on Total Knee Arthroplasty (TKA)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-05-21

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)

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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.

Conditions

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Wound Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Barbed suture group

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.

Group Type EXPERIMENTAL

"STRATAFIX™ Symmetric" Knotless Tissue

Intervention Type DEVICE

This devices will be used in deep and intermediate layers of barbed suture group.

"STRATAFIX Spiral" sutures

Intervention Type DEVICE

This devices will be used in intradermal layer of both barbed suture and conventional suture group.

DERMABOND™ Advance™ Skin Closure System

Intervention Type DEVICE

This devices will be used in skin layer of both barbed suture and conventional suture group.

Conventional suture group

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.

Group Type ACTIVE_COMPARATOR

VICRYL® PLUS

Intervention Type DEVICE

This devices will be used in deep and intermediate layers of conventional suture group.

"STRATAFIX Spiral" sutures

Intervention Type DEVICE

This devices will be used in intradermal layer of both barbed suture and conventional suture group.

DERMABOND™ Advance™ Skin Closure System

Intervention Type DEVICE

This devices will be used in skin layer of both barbed suture and conventional suture group.

Interventions

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"STRATAFIX™ Symmetric" Knotless Tissue

This devices will be used in deep and intermediate layers of barbed suture group.

Intervention Type DEVICE

VICRYL® PLUS

This devices will be used in deep and intermediate layers of conventional suture group.

Intervention Type DEVICE

"STRATAFIX Spiral" sutures

This devices will be used in intradermal layer of both barbed suture and conventional suture group.

Intervention Type DEVICE

DERMABOND™ Advance™ Skin Closure System

This devices will be used in skin layer of both barbed suture and conventional suture group.

Intervention Type DEVICE

Other Intervention Names

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STRATAFIX Symmetric Polyglactin 910 Spiral DERMABOND

Eligibility Criteria

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Inclusion Criteria

1. Patient is ≥ 18 years and \< 80 years of age;
2. Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;
3. Patient is willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent; and
4. Patient agrees not to schedule any additional elective surgical procedures until participation in this study is complete.

Exclusion Criteria

1. Female patient who is pregnant or lactating at the time of screening;
2. Patient has a Body Mass Index (BMI) \> 40 kg/m2;
3. Patient is not able to walk independently (inability to walk at least 10 consecutive meters without a walking aid);
4. Patient has had a surgical intervention during the past 30 days for treatment of painful joint or its underlying etiology;
5. Patient has had previous open surgeries on the affected joint other than arthroscopy;
6. Patient has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing;
7. Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®\* MP) or D\&C Violet No. 2;
8. Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0 mmol/L;
9. Patient has a history of immunosuppressive drug use, including steroids, within the last 6 months;
10. 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;
11. Patient has known personal or family history of keloid formation or hypertrophy;
12. Patient has other dermatologic conditions known to impair wound healing;
13. Patient is participating in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study;
14. Patient has any physical or psychological condition which would impair study participation; and
15. Patient is judged unsuitable for study participation by the investigator for any other reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No