Trials / Completed
CompletedNCT02399046
A Clinical Trial Study of Knee System in Primary Total Knee Arthroplasty in China
A Prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Knee Arthroplasty Devices Manufactured in China Versus Devices Manufactured Outside of China
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.
Detailed description
A prospective, Randomized, Multicenter, Controlled Study Comparing the Outcomes of Primary Total Knee Arthroplasty Devices Manufactured in China versus Devices Manufactured Outside of China.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Knee System made in China (Sigama, CoCr, PFC) | SIGAMA PS FEMUR; TIB tray Cem Cocr; SIGAMA STAB XLK INS; PFC SIG ROUND DOME PAT 3PEG |
| DEVICE | Total Knee System made outside of China (Sigama, NP, PFC) | SIGAMA PS CEM FEM; PFC MOD TIB TRAY NP; SIGAMA STAB XLK INS; PFC SIGAMA/RD/DOME PAT |
Timeline
- Start date
- 2017-08-17
- Primary completion
- 2019-07-10
- Completion
- 2019-10-25
- First posted
- 2015-03-26
- Last updated
- 2019-11-18
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02399046. Inclusion in this directory is not an endorsement.