A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II CR Total Knee System
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Arthroplasty
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 62
- Locations
- 8
- Primary Endpoint
- Oxford Knee Score (OKS) at 2 Years
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
Brief Summary
Background:
The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM)
Purpose:
Post-market evidence generation for JOURNEY II CR Total Knee System
Objectives:
Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA
Research participants / locations:
A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with degenerative osteoarthritis.
- •Subject is planning to have TKA using JOURNEY II CR.
- •Subject is able and willing to provide voluntary consent to study participation.
- •Subject is 18-80 years old (inclusive) \* (\* For Japan, the minimum inclusion age is 20 years old.)
Exclusion Criteria
- •Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
- •Previous surgeries including HTO, UKA or TKA on the subject knee.
- •Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up.
- •Subject does not meet the indication or is contraindicated for JOURNEY II CR's IFU.
Outcomes
Primary Outcomes
Oxford Knee Score (OKS) at 2 Years
Time Frame: 2 years
The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
Secondary Outcomes
- Forgotten Joint Score (FJS)(6 months, 1 year, 2 years, 3 years)
- Oxford Knee Score (OKS)(Pre-Operative, 6 months, 1 year, 3 years)
- Knee Society Score (KSS): "Objective" Knee Score(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Knee Society Score (KSS): Patient Satisfaction Score(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Knee Society Score (KSS): Patient Expectation Score(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Knee Society Score (KSS): Functional Knee Score(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Patient Expectation(Pre-Operative)
- Patient Satisfaction(6 months, 1 year, 2 years, 3 years)
- Radiographic Assessment: Presence of Radiographic Findings(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Aseptic Loosening(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Septic Loosening(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Bone Fracture(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Implant-Cement Debonding(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Cement Fracture(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Osteolysis(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Subsidence(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Implant Migration(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Stress Shielding(Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years)
- Radiographic Assessment: Mechanical Axis Alignment of the Knee Joint(Pre-Operative, 6 months, 1 year, 2 years)