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)

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.

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.

All efficacy endpoints will be summarized descriptively by treatment group. The continuous variables will be summarized descriptively by number of subjects, mean, standard deviation, minimum, and maximum. Categorical data will be summarized descriptively by frequencies along with the associated percentages.

42 days

An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.