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

Terminated

• Conditions: Osteoarthritis; Degenerative Arthritis; Traumatic Arthritis

• Registration Number: NCT02820766
• Lead Sponsor: Smith & Nephew, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Study Start: 2016-09
• Primary Completion: 2017-04-27
• Study Completion: 2017-04-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

University Orthopaedic Center; 🇺🇸 State College, Pennsylvania, United States

Anne Arundel Medical Cneter; 🇺🇸 Annapolis, Maryland, United States

Slocum Research & Educational Foundation; 🇺🇸 Eugene, Oregon, United States