Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting

Study Overview
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Brief Summary
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The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer. To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.

Official Title
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A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting

Conditions
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Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith & Nephew Posterior Stabilized Knee System Will be initiating outpatient PT ≤ 7 days post-operatively Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis Has pre-operative ROM ≥ 90° Is skeletally mature in the PI judgment Is 21 years of age of older Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires Has consented to participate in the study by signing the IRB/EC approved informed consent for the study Agrees to follow post- operative physical therapy program Exclusion Criteria: Significant preoperative varus or valgus deformities (>15º) Has received a constrained or deep dish tibial insert Morbid obesity (BMI > 40) Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection Fibromyalgia requiring treatment Current or impending incarceration or is a prisoner In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse Is known to be at risk for lost to follow-up, or failure to return for scheduled visits Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement Requires a Legally Authorized Representative to consent to the study

Ages Eligible for Study
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Minimum Age: 21 Years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Journey II BCS Knee<br>Physical Therapy Observational | |
| All Other Posterior Stabilized Knees<br>Physical Therapy Observational | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups | The absolute Range of Motion of index knee will be compared between groups | ≤7 days of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior Stabilized Knee, Total Knee Arthroscopy, Journey II BCS