Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations
NCT ID: NCT04822259
Last Updated: 2022-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-08-28
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JOURNEY II BCS TKA
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
JOURNEY II BCS Total Knee System
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
JOURNEY II CR TKA
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System
JOURNEY II CR Total Knee System
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System
Interventions
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JOURNEY II BCS Total Knee System
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
JOURNEY II CR Total Knee System
Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Astrid Yung
Role: STUDY_DIRECTOR
Smith & Nephew, Inc.
Locations
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Peking University Third Hospital
Beijing, , China
Prince of Wales Hospital
Hong Kong, , China
Aster RV Hospital, Bangalore
Bengaluru, Karnataka, India
Noble Hospital & Ruby Hall Clinic
Pune, Maharashtra, India
Singapore General Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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Journey II CR + BCS.2020.12
Identifier Type: -
Identifier Source: org_study_id
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