Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
Stopped early
Conditions studied: Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT02820766
- Run by
- Smith & Nephew, Inc.
- People needed
- 22
- Starts
- 2016-09-01
- Expected to finish
- 2017-04-27
- Last updated by the study team
- 2017-08-10
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anne Arundel Medical Cneter — Annapolis, Maryland, United States
- Slocum Research & Educational Foundation — Eugene, Oregon, United States
- University Orthopaedic Center — State College, Pennsylvania, United States
Full record on ClinicalTrials.gov
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