Clinical trial NCT04822259: Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
Official title: A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II BCS and CR Total Knee System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Keywords: Osteoarthritis
Total knee arthroplasty (TKA)
Cruciate Retaining (CR)
Bi-cruciate Stabilized (BCS)
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM)

The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM)

Purpose:

Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System

Objectives:

1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations
2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR

Research participants / locations:

A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.


Eligibility criteria: Inclusion Criteria:

* Subjects with degenerative osteoarthritis.
* Subject is planning to have bilateral Total Knee Arthroplasty (TKA) using JOURNEY II BCS \& CR or have unilateral TKA using JOURNEY II BCS or JOURNEY II CR.\*
* Subject is able and willing to provide voluntary consent to study participation.
* Subject is 18-80 years old (inclusive).

\[\* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)\]

Exclusion Criteria:

* Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
* Previous surgeries including High Tibial Osteotomy (HTO), Unicondylar Knee Arthroplasty (UKA) or Total Knee Arthroplasty (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 BCS \& JOURNEY II CR's Instructions For Use (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, 6 months, 1 year, 2 years, 3 years
measure: Timed Up and Go Test (TUG)
timeFrame: Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year
measure: Star Excursion Balance Test (SEBT)
timeFrame: Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year
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: Noble Hospital & Ruby Hall Clinic
state: Maharashtra
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Smith & Nephew, Inc.
name: Astrid Yung
role: STUDY_DIRECTOR
References: