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Symmetric on Total Knee Arthroplasty (TKA)
Symmetric on Total Knee Arthroplasty (TKA)

NCT03305887

CompletedNA

Sponsor: Johnson & Johnson Medical, China

Conditions: Wound Closure

Interventions: "STRATAFIX™ Symmetric" Knotless Tissue, VICRYL® PLUS, "STRATAFIX Spiral" sutures, DERMABOND™ Advance™ Skin Closure System

Countries: China

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)

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (7)
  • Beijing, Beijing Municipality, China
  • Guangzhou, Guangdong, China
  • Wuhan, Hubei, China
  • Nanjing, Jiangsu, China
  • Changchun, Jilin, China
  • Xi’an, Shanxi, China
  • Hangzhou, Zhejiang, China