Pilot Study of the KineSpring® System to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis (SOAR)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Moximed
ClinicalTrials.gov Identifier:
NCT01738165
First received: November 28, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The purpose of this pilot study is to collect data on the safety and effectiveness of the KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.


Condition Intervention
Osteoarthritis of the Knee
Device: KineSpring Knee Implant System (KineSpring System)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Moximed:

Primary Outcome Measures:
  • The primary endpoint of this pilot study is the rate of individual patient success at 24 months. [ Time Frame: 24 months post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary effectiveness endpoint [ Time Frame: Assessed preprocedure and at 6 weeks and 3, 6, 12, 24, 36, 48, 60 mths post procedure ] [ Designated as safety issue: No ]
    EuroQol (EQ-5D) Patient Reported Outcome measure.

  • Secondary Safety Endpoints [ Time Frame: At time of procedure and through 60 month follow-up ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ] [ Designated as safety issue: No ]
    High-Activity Arthroplasty Score (HAAS) Patient Reported Outcome measure.

  • Secondary effectiveness endpoint [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ] [ Designated as safety issue: No ]
    Knee Pain Severity Score using a Visual Analogue Scale (VAS) (0-100).

  • Secondary effectiveness endpoint [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ] [ Designated as safety issue: No ]
    Knee injury and Osteoarthritis Outcome Score (KOOS) Patient Reported Outcome measure

  • Secondary effectiveness endpoint [ Time Frame: Assessed preprocedure, 6 weeks, and 3, 6, 12, 24, 36, 48, 60 mths post procedure ] [ Designated as safety issue: No ]
    Participant Global Assessment: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed preprocedure, pre-hospital discharge, and 3, 12, and 60 mths post procedure ] [ Designated as safety issue: Yes ]
    Radiographic assessment to evaluate radiographic changes.

  • Secondary Imaging Endpoints [ Time Frame: Assessed preprocedure and at 24 months post procedure ] [ Designated as safety issue: Yes ]
    MRI assessment to evaluate MRI changes.


Estimated Enrollment: 60
Study Start Date: December 2012
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KineSpring System
In this single arm study, the KineSpring System will be surgically implanted in all 60 study patients.
Device: KineSpring Knee Implant System (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)

Detailed Description:

The KineSpring System is indicated to treat symptoms of pain and loss of knee function in patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee. The KineSpring System is indicated for patients with osteoarthritis of severity that does not require knee joint replacement.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with symptoms of knee pain and loss of knee function.
  • Patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee.
  • Radiographic confirmation of mild to moderate medial compartment knee OA

Exclusion Criteria:

  • Patients that that require knee joint replacement.
  • Symptomatic OA in lateral compartment or patellofemoral compartment.
  • Known sensitivity to metals including cobalt, chromium, iron, or nickel
  • Rheumatoid arthritis, other forms of inflammatory joint disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738165

Locations
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
OrthoCarolina
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
Sponsors and Collaborators
Moximed
Investigators
Principal Investigator: Jack Farr, MD OrthoIndy Knee Care Institute
  More Information

No publications provided

Responsible Party: Moximed
ClinicalTrials.gov Identifier: NCT01738165     History of Changes
Other Study ID Numbers: KINE-1203
Study First Received: November 28, 2012
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Moximed:
Prospective
Multi-Center
Pilot Study
Single Arm
Safety
Efficacy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 18, 2014