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 |
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.
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
Cincinnati, Ohio 45219
Phone: 513-585-1699
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Annapolis, Maryland 21401
Principal Investigator: Kiley Holmes, PT
Phone: 443-481-5757
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