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



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:21 - Any
Updated:12/17/2016
Start Date:September 2016
End Date:October 2017
Contact:Jane Solomon
Email:jane.solomon@smith-nephew.com
Phone:978 749 1558

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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

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.


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
We found this trial at
4
sites
State College, Pennsylvania 16801
Phone: 814-272-3751
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State College, PA
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Annapolis, Maryland 21401
Principal Investigator: Kiley Holmes, PT
Phone: 443-481-5757
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Annapolis, MD
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Cincinnati, OH
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Eugene, Oregon 97401
Phone: 541-868-3232
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Eugene, OR
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