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

April 26, 2017 updated by: Cotera, Inc.
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Slotervaart Hospital
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Geldrop, Netherlands
        • St. Anna Hospital
      • Maastricht, Netherlands
        • University Hospital Maastricht
      • Zwolle, Netherlands
        • Isala
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clinic
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Fundación Jiménez Díaz
  • United Kingdom
      • London, United Kingdom
        • Royal London Hospital
      • Norwich, United Kingdom
        • Norfolk & Norwich University Hospital
      • Swansea, United Kingdom
        • Morriston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in knee outcome measures (KOOS, IKDC, NRS)
Time Frame: 6, 12 and 24 months
6, 12 and 24 months
Device and procedure complication rates
Time Frame: 6, 12 and 24 months
6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cotera, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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