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

NCT02820766 | Terminated

• 1 other identifier: Journey II BCS CMS Study
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis; Degenerative Arthritis; Traumatic Arthritis

Keywords

Posterior Stabilized Knee; Total Knee Arthroscopy; Journey II BCS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Journey II BCS Knee

Physical Therapy Observational

All Other Posterior Stabilized Knees

Physical Therapy Observational

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (3)

Anne Arundel Medical Cneter

Annapolis, Maryland, 21401, United States

Location

Slocum Research & Educational Foundation

Eugene, Oregon, 97401, United States

Location

University Orthopaedic Center

State College, Pennsylvania, 16801, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Beate Hanson, MD

  Smith & Nephew, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: September 1, 2016
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)