Degenerative Arthritis, Osteoarthritis, Traumatic Arthritis
Conditions
Keywords
Posterior Stabilized Knee, Total Knee Arthroscopy, Journey II BCS
Brief summary
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.
Interventions
None listed
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups | ≤7 days of surgery | The absolute Range of Motion of index knee will be compared between groups |
Countries
United States
Outcome results
None listed