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

Cotera, Inc.1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Latella Knee Implant SystemDEVICE

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

The George Washington University

Washington D.C., District of Columbia, United States

Rush University Medical Center

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 Months