Clinical trial NCT02820766: Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis
Degenerative Arthritis
Traumatic Arthritis
Keywords: Posterior Stabilized Knee
Total Knee Arthroscopy
Journey II BCS
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
timeFrame: ≤7 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Cneter
state: Maryland
city: Eugene
country: United States
facility: Slocum Research & Educational Foundation
state: Oregon
city: State College
country: United States
facility: University Orthopaedic Center
state: Pennsylvania
Study officials:
affiliation: Smith & Nephew, Inc.
name: Beate Hanson, MD
role: STUDY_DIRECTOR
References: