Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Cotera, Inc.67 enrolled

Overview

The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee 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 (12)

Slotervaart Hospital

Amsterdam, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

St. Anna Hospital

Geldrop, Netherlands

University Hospital Maastricht

Outcomes

Primary Outcomes

Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant

Time frame: 6 Months

Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device

Time frame: 6 Months

Secondary Outcomes

Changes in knee outcome measures (KOOS, IKDC, NRS)

Time frame: 6, 12 and 24 months

Device and procedure complication rates

Time frame: 6, 12 and 24 months

Data from ClinicalTrials.gov

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