Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Device: Latella Knee Implant System

• Registration Number: NCT02608957
• Lead Sponsor: Cotera, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Study Start: 2015-12
• Primary Completion: 2016-05
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Latella Knee Implant System	Latella Knee Implant System	-

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Surgical re-intervention rate at 6 months	6 Months	Surgical re-intervention rate during the 6 month period following implantation of the Latella device.
Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months	6 Months	Mean change in KOOS pain score at 6 months after treatment with the Latella Implant.

Secondary Outcome Measures

Name	Time	Method
Device-related complications rate	24 months
Change in KOOS pain score	12 and 24 months
Surgical re-intervention rate	12 and 24 months
Procedure-related complications rate	24 Months
Change in medial knee pain NRS (while walking)	6, 12 and 24 months
Change in KOOS function score	6, 12 and 24 months
Change in IKDC score	6, 12 and 24 months
Proportion of subjects reaching MCID in KOOS pain score	6, 12 and 24 months
KOOS responder rate based on OARSI-OMERACT criteria	6, 12 and 24 months

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

The George Washington University; 🇺🇸 Washington, District of Columbia, United States