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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis; Degenerative Arthritis; Traumatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Cneter
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Slocum Research & Educational Foundation
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • University Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis and who will receive either the Journey II BCS knee or any other posterior stabilized knee.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Journey II BCS Knee; Physical Therapy Observational
All Other Posterior Stabilized Knees; Physical Therapy Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups	The absolute Range of Motion of index knee will be compared between groups	≤7 days of surgery

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Director: Beate Hanson, MD, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): April 27, 2017
• Study Completion (Actual): April 27, 2017

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Posterior Stabilized Knee; Total Knee Arthroscopy; Journey II BCS
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Journey II BCS CMS Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study terminated therefore no data sharing planned