Trials / Unknown
UnknownNCT03442231
Journey™ UNI Post Market Clinical Follow-Up
Follow-Up of Subjects With a Journey™ UNI Unicompartmental Knee System Implant
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 147 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.
Detailed description
The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Journey UNI Unicompartmental Knee System | Lateral or medial knee compartment replacement |
Timeline
- Start date
- 2018-04-11
- Primary completion
- 2025-04-11
- Completion
- 2025-04-11
- First posted
- 2018-02-22
- Last updated
- 2024-02-20
Locations
4 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03442231. Inclusion in this directory is not an endorsement.