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Symmetric on Total Knee Arthroplasty (TKA)
NA trial testing "STRATAFIX™ Symmetric" Knotless Tissue in Wound Closure in 184 participants. Completed in 21 May 2018.
| Lead sponsor | Johnson & Johnson Medical, China |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 184 |
| Start date | 12 June 2017 |
| Primary completion | 13 April 2018 |
| Estimated completion | 21 May 2018 |
| Sites | 7 locations across China |
Johnson & Johnson Medical, China
Adults 18 to 79, any sex, with Wound Closure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The total time required to close the surgical incisions between treatment groups.
| Group | Value | 95% CI |
|---|---|---|
| STRATAFIX Symmetric PDS Plus | 15.516 | 3.083 – 30.200 |
| Conventional Sutures | 20.864 | 10.267 – 43.617 |
Time frame: 42 days. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | STRATAFIX Symmetric PDS Plus | Conventional Sutures |
|---|---|---|---|
| Postoperative pain/postoperative exudation | Musculoskeletal and connective tissue disorders | — | — |
| Incision subcutaneous hemorrhage and Incision exudate | Skin and subcutaneous tissue disorders | — | — |
| inflammatory reaction | Skin and subcutaneous tissue disorders | — | — |
| Incision infection | Musculoskeletal and connective tissue disorders | — | — |
| Pain after knee replacement | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | STRATAFIX Symmetric PDS Plus | Conventional Sutures |
|---|---|---|---|
| inflammatory reaction | Skin and subcutaneous tissue disorders | — | — |
| Incision inflammation | Skin and subcutaneous tissue disorders | — | — |
| seepage of wound | Musculoskeletal and connective tissue disorders | — | — |
| white blood cell increment | Blood and lymphatic system disorders | — | — |
| red blood cell decrement | Blood and lymphatic system disorders | — | — |
| monocytes increment | Blood and lymphatic system disorders | — | — |
| Limb swelling （left） | Musculoskeletal and connective tissue disorders | — | — |
| Hemorrhagic seepage of wound | Musculoskeletal and connective tissue disorders | — | — |
| Tension vesicle around the wound | Musculoskeletal and connective tissue disorders | — | — |
| Hemorrhagic infiltration of wound | Musculoskeletal and connective tissue disorders | — | — |
| Hemorrhagic seepage of wound | Skin and subcutaneous tissue disorders | — | — |
| lower limb swelling | Musculoskeletal and connective tissue disorders | — | — |
| hypokalemia | Blood and lymphatic system disorders | — | — |
| Contagious eczema rash | Skin and subcutaneous tissue disorders | — | — |
| drug fever | Immune system disorders | — | — |
| hypoalbuminemia | Blood and lymphatic system disorders | — | — |
Most-reported serious reactions: Postoperative pain/postoperative exudation, Incision subcutaneous hemorrhage and Incision exudate, inflammatory reaction, Incision infection, Pain after knee replacement.
Data from ClinicalTrials.gov NCT03305887 adverse events section.
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)
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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