A Clinical Trial Study of Knee System in Primary Total Knee Arthroplasty in China
NCT02399046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2019-11-18
Summary
A clinical trial of total knee system used in Primary Total Knee Arthroplasty in China.
Conditions
- Arthritis, Rheumatoid
- Osteoarthritis
- Post-traumatic; Arthrosis
Interventions
- 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
Sponsors & Collaborators
-
Johnson & Johnson Medical (Suzhou) Ltd.
lead INDUSTRY
Principal Investigators
-
Fuxing Pei · The West China Hospital of Sichuan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-17
- Primary Completion
- 2019-07-10
- Completion
- 2019-10-25
Countries
- China
Study Locations
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