Status:
COMPLETED
Symmetric on Total Knee Arthroplasty (TKA)
Lead Sponsor:
Johnson & Johnson Medical, China
Collaborating Sponsors:
Second Affiliated Hospital of Xi'an Jiaotong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Wound Closure
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
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 PD...
Detailed Description
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 undergoi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2018
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03305887
Start Date
June 12 2017
End Date
May 21 2018
Last Update
January 13 2020
Active Locations (7)
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1
Chinese PLA general hospital
Beijing, Beijing Municipality, China, 100000
2
NanFang Hospital
Guangzhou, Guangdong, China, 510000
3
Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&technology
Wuhan, Hubei, China, 430000
4
Jiangsu province hospital
Nanjing, Jiangsu, China, 210000