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

Not Applicable

Terminated

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

• Registration Number: NCT02343705
• Lead Sponsor: Cotera, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-22
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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 Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant	6 Months
Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device	6 Months

Secondary Outcome Measures

Name	Time	Method
Device and procedure complication rates	6, 12 and 24 months
Changes in knee outcome measures (KOOS, IKDC, NRS)	6, 12 and 24 months

Trial Locations

Locations (12)

Slotervaart Hospital; 🇳🇱 Amsterdam, Netherlands

St. Anna Hospital; 🇳🇱 Geldrop, Netherlands

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Hospital Clinic; 🇪🇸 Barcelona, Spain

Isala; 🇳🇱 Zwolle, Netherlands

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Royal London Hospital; 🇬🇧 London, United Kingdom

Morriston Hospital; 🇬🇧 Swansea, United Kingdom

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom