Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US)

Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Latella Knee Implant System

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Latella Knee Implant System	Device: Latella Knee Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 Months
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.	6 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in KOOS function score	6, 12 and 24 months
Change in medial knee pain NRS (while walking)	6, 12 and 24 months
Change in IKDC score	6, 12 and 24 months
Device-related complications rate	24 months
KOOS responder rate based on OARSI-OMERACT criteria	6, 12 and 24 months
Proportion of subjects reaching MCID in KOOS pain score	6, 12 and 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

Collaborators and Investigators

• Sponsor: Cotera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CIP-0002