Trials / Completed
CompletedNCT01705067
Safety and Efficacy of the Journey II BCS Total Knee System
A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 209 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
Detailed description
Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TKA with Journey II BCS Total Knee System | TKA with Journey II BCS Total Knee System |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2012-10-12
- Last updated
- 2024-06-13
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01705067. Inclusion in this directory is not an endorsement.