Safety and Efficacy of the Journey II BCS Total Knee System

Study Overview
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Brief Summary
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Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Detailed Description
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Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.

Official Title
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A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: TKA with Journey II BCS Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease Subject is willing to sign and date an IRB approved consent form Subject is of legal age to consent Subject plans to be available through ten (10) years postoperative follow-up Subject agrees to follow the study protocol Exclusion Criteria: Subject received the JOURNEY™ II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty Subject possesses a contralateral or ipsilateral revision hip arthroplasty Subject has ipsilateral hip arthritis resulting in flexion contracture At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty Contralateral primary total knee or unicondylar knee arthroplasty At the time of surgery, subject had an active infection or sepsis (treated or untreated) At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation Subject is pregnant or plans to become pregnant during the study Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study At the time of surgery, subject had a BMI>40 At the time of enrollment, subject has a BMI>40 Subject is enrolled in another investigational drug, biologic, or device study Subject is facing current or impending incarceration
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Journey II BCS TKA<br>Subjects having TKA with Journey II BCS Total Knee System | Device: TKA with Journey II BCS Total Knee System<br>* TKA with Journey II BCS Total Knee System<br>* Other names: Journey II BCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ITB Friction Pain |  | 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively | 
| Radiographic Evaluation |  | Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively | 
| Knee Society Score |  | 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Degenerative Knee Disease, TKA