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

Smith & Nephew, Inc.3 sites in 1 country22 target enrollmentSeptember 2016

ConditionsOsteoarthritis Degenerative Arthritis Traumatic Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Smith & Nephew, Inc.
Enrollment: 22
Locations: 3
Primary Endpoint: Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2016

End Date

April 27, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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