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

NCT ID: NCT02820766

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-27

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Journey II BCS Knee

Physical Therapy Observational

No interventions assigned to this group

All Other Posterior Stabilized Knees

Physical Therapy Observational

No interventions assigned to this group

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
• Requires a Legally Authorized Representative to consent to the study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beate Hanson, MD

Role: STUDY_DIRECTOR

Smith & Nephew, Inc.

Locations

Anne Arundel Medical Cneter

Annapolis, Maryland, United States

Slocum Research & Educational Foundation

Eugene, Oregon, United States

University Orthopaedic Center

State College, Pennsylvania, United States

Countries

United States

Other Identifiers

Journey II BCS CMS Study

Identifier Type: -

Identifier Source: org_study_id