Study of the KineSpring® System to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis (SOAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01738165|
Recruitment Status : Active, not recruiting
First Posted : November 30, 2012
Last Update Posted : June 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Knee||Device: KineSpring System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multi-Center, Pilot Study to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis (OA) Treated With the KineSpring® Knee Implant for Load Reduction|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||June 2020|
Experimental: KineSpring System
Surgical intervention In this single arm study, the KineSpring System will be surgically implanted in up to 110 study patients.
Device: KineSpring System
The KineSpring System is designed to treat pain and loss of function secondary to medial knee OA by absorbing joint overload.
Other Name: Arthroplasty, Unicompartmental Knee Arthroplasty (UKA)
- The primary endpoint of this pilot study is the rate of individual patient success at 24 months. [ Time Frame: 24 months post procedure ]
- Secondary effectiveness endpoint - EuroQol (EQ-5D) [ Time Frame: Assessed preprocedure and at 6 weeks and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Patient Reported Outcome measure.
- Secondary Safety Endpoints [ Time Frame: At time of procedure and through 60 month follow-up ]Safety outcomes will be determined by evaluating by the type, frequency, severity, and relatedness of adverse events through the 60 month timepoint.
- Secondary effectiveness endpoint - High-Activity Arthroplasty Score (HAAS) [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Patient Reported Outcome measure.
- Secondary effectiveness endpoint - VAS [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Knee Pain Severity Score using a Visual Analogue Scale (VAS) (0-100).
- Secondary effectiveness endpoint - KOOS [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Knee injury and Osteoarthritis Outcome Score (KOOS) Patient Reported Outcome measure
- Secondary effectiveness endpoint - Participant Global Assessment [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Patient's assessment of their global status based on their OA.
- Secondary effectiveness endpoint [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ]Western Ontario and McMaster Universities Arthritis (WOMAC) Patient Reported Outcome measure. KOOS contains the full and original version of the WOMAC questionnaire and thus WOMAC scores will be calculated from the KOOS questionnaire.
- Secondary Imaging Endpoints - Radiographic [ Time Frame: Assessed preprocedure, pre-hospital discharge, and 3, 12, and 60 mths post procedure ]Radiographic assessment to evaluate radiographic changes.
- Secondary Imaging Endpoints - MRI [ Time Frame: Assessed preprocedure and at 24 months post procedure ]MRI assessment to evaluate MRI changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738165
|United States, California|
|Orthopaedic Institute, University of California|
|San Francisco, California, United States, 94158|
|United States, Florida|
|Jupiter Medical Center|
|West Palm Beach, Florida, United States, 33407|
|United States, Indiana|
|Orthropaedic Research Foundation|
|Greenwood, Indiana, United States, 46143|
|United States, Minnesota|
|University of Minnesota, Department of Orthopaedic Surgery|
|Minneapolis, Minnesota, United States, 55454|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|Duke University Medical Center Sports Medicine|
|Durham, North Carolina, United States, 27710|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Virginia|
|Univerisy of Virginia, Dept. of Orthopaedic Surgery|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Jack Farr, MD||OrthoIndy Knee Care Institute|