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

Smith & Nephew

Status: Terminated

Conditions: Traumatic Arthritis; Osteoarthritis; Degenerative Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02820766

Journey II BCS CMS Study

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

22 participants in 2 patient groups

Journey II BCS Knee

Description:

Physical Therapy Observational

All Other Posterior Stabilized Knees

Description:

Physical Therapy Observational