Back to resultsEvaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US)
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Latella Knee Implant System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- History of pain due to medial osteoarthritis
- Qualifying baseline pain scores
- Kellgren-Lawrence Grades 2-3
Exclusion Criteria:
- Osteoporosis
- Rheumatoid arthritis
- Joint instability
- Metal ion allergy
- Permanent implant in or around the knee joint
- Prior anterior cruciate ligament reconstruction
Sites / Locations
- The George Washington University
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Latella Knee Implant System
Arm Description
Outcomes
Primary Outcome Measures
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.
Primary Safety Endpoint: Surgical re-intervention rate at 6 months
Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
Secondary Outcome Measures
Change in KOOS function score
Change in medial knee pain NRS (while walking)
Change in IKDC score
Device-related complications rate
KOOS responder rate based on OARSI-OMERACT criteria
Proportion of subjects reaching MCID in KOOS pain score
Change in KOOS pain score
Surgical re-intervention rate
Procedure-related complications rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02608957
Brief Title
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
Acronym
Latella-US
Official Title
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor elected to terminate the study prior to subject treatment.
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cotera, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (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
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
Description
Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.
Time Frame
6 Months
Title
Primary Safety Endpoint: Surgical re-intervention rate at 6 months
Description
Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change in KOOS function score
Time Frame
6, 12 and 24 months
Title
Change in medial knee pain NRS (while walking)
Time Frame
6, 12 and 24 months
Title
Change in IKDC score
Time Frame
6, 12 and 24 months
Title
Device-related complications rate
Time Frame
24 months
Title
KOOS responder rate based on OARSI-OMERACT criteria
Time Frame
6, 12 and 24 months
Title
Proportion of subjects reaching MCID in KOOS pain score
Time Frame
6, 12 and 24 months
Title
Change in KOOS pain score
Time Frame
12 and 24 months
Title
Surgical re-intervention rate
Time Frame
12 and 24 months
Title
Procedure-related complications rate
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of pain due to medial osteoarthritis
Qualifying baseline pain scores
Kellgren-Lawrence Grades 2-3
Exclusion Criteria:
Osteoporosis
Rheumatoid arthritis
Joint instability
Metal ion allergy
Permanent implant in or around the knee joint
Prior anterior cruciate ligament reconstruction
Facility Information:
Facility Name
The George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
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