Trials / Active Not Recruiting
Active Not RecruitingNCT03136887
JOURNEY II XR Safety and Effectiveness PMCF
A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 176 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study was designed to demonstrate the safety and performance of the JOURNEY II XR total knee system by evaluating implant survival rates at 10 years using Kaplan-Meier analysis. All participants will be implanted with the JOURNEY II XR total knee system.
Detailed description
Total knee arthroplasty (TKA) is considered the most beneficial and cost-effective treatment for end-stage knee arthritis and is the most frequently performed joint replacement surgery. TKA is also indicated for earlier osteoarthritis (OA) interventions, such as osteotomy or unicompartmental replacement, when additional treatment is warranted. One device option available once the decision is made to perform TKA is the JOURNEY II XR Total Knee System. The JOURNEY II XR Total Knee System is designed to be a more "natural feeling" total knee replacement. The goal of the JOURNEY II XR is to enable a higher level of function after total knee replacement by relieving pain and restoring the ability to participate in active lifestyles. The main aim of this study is to generate long-term safety and performance data for the JOURNEY™ II XR Total Knee System. Effectiveness information such as short- and long-term function, subject satisfaction, and quality of life will also be measured.
Conditions
- Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee
- Unilateral Post-Traumatic Osteoarthritis of Knee
- Knee Osteoarthritis
- Degenerative Arthritis Peripheral Joint
- Failed Osteotomies
- Failed Unicompartmental Replacement
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | JOURNEY II XR Total Knee System | JOURNEY II XR Total Knee System |
Timeline
- Start date
- 2017-07-28
- Primary completion
- 2029-04-01
- Completion
- 2029-04-01
- First posted
- 2017-05-02
- Last updated
- 2024-08-12
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03136887. Inclusion in this directory is not an endorsement.