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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02820766
• Other study ID #: Journey II BCS CMS Study
• Status: Terminated
• Phase: N/A
• First received: June 29, 2016
• Last updated: August 8, 2017
• Start date: September 2016
• Est. completion date: April 27, 2017

Study information

• Verified date: August 2017
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Degenerative Arthritis
• Osteoarthritis
• Traumatic Arthritis

Locations

Country	Name	City	State
United States	Anne Arundel Medical Cneter	Annapolis	Maryland
United States	Slocum Research & Educational Foundation	Eugene	Oregon
United States	University Orthopaedic Center	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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