A Prospective, Multicenter, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of the JOURNEY™ II XR Total Knee System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rheumatoid Vasculitis With Rheumatoid Arthritis of Knee
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 176
- Locations
- 14
- Primary Endpoint
- Implant survival rate
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •require TKA due to rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, failed osteotomies, or failed unicompartmental replacement
- •have all cruciate and collateral ligaments intact in the index joint
- •adult patients that in the judgement of the Investigator are skeletally mature
- •be willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires
- •consent to participate in the study by signing the IRB/EC approved informed consent form
Exclusion Criteria
- •have any of the following conditions in the index joint:
- •Intra-articular corticosteroid therapy (or any other intra-articular therapy) in the study knee within 3 months of study enrollment
- •Significant varus or valgus deformities (\>15º)
- •Incomplete or insufficient tissue surrounding the knee
- •Collateral ligament insufficiency
- •Inadequate bone stock to support the device (e.g., severe osteopenia/osteoporosis) or will require use of femoral and tibial stems
- •History of prior TKA
- •have any of the following conditions in the contralateral joint:
- •a previous TKA as a revision for a failed total or unicondylar knee arthroplasty
- •a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning as determined by the Investigator
Outcomes
Primary Outcomes
Implant survival rate
Time Frame: 10 years
Did knee survive with no revision through 10 years
Secondary Outcomes
- Quality of Life - FJS(10 years)
- Quality of Life - KOOS(10 years)
- Physiotherapy (PT) utilization - Period of visits(6 Months Post-operatively)
- Quality of Life - ABC scale(10 years)
- Radiographic outcomes(10 years)
- Adverse Events (AEs)(10 years)
- Knee function(10 years)
- Quality of Life - EQ-5D - 3L(10 years)
- Quality of Life - SAPSS(10 years)
- Physiotherapy (PT) utilization - No. of visits(6 Months Post-operatively)