Back to resultsFeasibility of the Latella Implant System for Medial Osteoarthritis (OA)
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Latella Knee Implant System
Sponsored by
About this trial
This is an interventional device feasibility trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- History of pain as due to medial osteoarthritis
Exclusion Criteria:
- Rheumatoid arthritis
- Joint or ligament instability
- Metal ion allergy
Sites / Locations
- Slotervaart Hospital
- Barts Health NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Latella Knee Implant System
Arm Description
Outcomes
Primary Outcome Measures
Freedom from unanticipated serious adverse device effects
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02002637
Brief Title
Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)
Official Title
Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients With Medial Osteoarthritis - A Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor election
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cotera, Inc.
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latella Knee Implant System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Latella Knee Implant System
Primary Outcome Measure Information:
Title
Freedom from unanticipated serious adverse device effects
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of pain as due to medial osteoarthritis
Exclusion Criteria:
Rheumatoid arthritis
Joint or ligament instability
Metal ion allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Ramachandran, MD
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slotervaart Hospital
City
Amsterdam
Country
Netherlands
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)
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