NCT02820766TerminatedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 22
- Locations
- 3
- Primary Endpoint
- Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
Time Frame: ≤7 days of surgery
The absolute Range of Motion of index knee will be compared between groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Recruiting
Unknown
To Analyze the immediate and long-term effectiveness of WinHealth’s DTx platform to prevent and improve symptoms of irritable bowel syndrome (IBS)CTRI/2023/11/059987Mr. Shashank Mishra
Completed
Not Applicable
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using ShapeMatch® Cutting Guides: Sub-Study BArthroplasties, Replacement, KneeNCT02527161Stryker South Pacific205
Completed
Not Applicable
Monitoring of Babies' Heart Rates During Labour Using Mobile MonitorsFetal AcidemiaNCT03922854Sheffield Teaching Hospitals NHS Foundation Trust200
Completed
Not Applicable
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral RectopexyRectal ProlapseNCT04130555Meccellis Biotech55
Recruiting
Not Applicable
Effectiveness of the Suicidal Crisis Intervention (SCI)SuicideSuicide, AttemptedSuicidal IdeationNCT05638204University Hospital, Ghent390