Clinical trial NCT04818840: Evaluate the Performance of JOURNEY II CR in TKA Populations
Official title: A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II CR Total Knee System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthroplasty
Replacement
Knee
Keywords: Osteoarthritis
Total knee arthroplasty (TKA)
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.

Primary outcomes:
measure: Oxford Knee Score (OKS) at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Forgotten Joint Score (FJS)
timeFrame: 6 months, 1 year , 2 years , 3 years
measure: Oxford Knee Score (OKS)
timeFrame: Pre-Operative, 6 months, 1 year, 3 years
measure: Knee Society Score (KSS)
timeFrame: Pre-Operative, 6 months, 1 year, 2 years, 3 years
measure: Patient Expectation
timeFrame: Pre-Operative
measure: Patient Satisfaction
timeFrame: 6 months, 1 year, 2 years, 3 years
measure: Radiographic Assessment
timeFrame: Pre-Operative, Immediate Post-op to 6 weeks, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Hong Kong
country: China
facility: Prince of Wales Hospital
city: Bengaluru
country: India
facility: Aster RV Hospital, Bangalore
state: Karnataka
city: Pune
country: India
facility: Arcus Hospital
state: Maharashtra
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Smith & Nephew, Inc.
name: Julian Yang
role: STUDY_DIRECTOR
References: