Safety and Efficacy of the Journey II BCS Total Knee System

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2023-07-31

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.

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Journey II BCS TKA

Subjects who previously received TKA with Journey II BCS Total Knee System

TKA with Journey II BCS Total Knee System

Intervention Type DEVICE

TKA with Journey II BCS Total Knee System

Interventions

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TKA with Journey II BCS Total Knee System

Intervention Type DEVICE

Other Intervention Names

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Journey II BCS

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No