Feasibility of the Latella Implant System for Medial Osteoarthritis (OA)

April 26, 2017 updated by: Cotera, Inc.

Evaluation of the Latella Implant System for Lateralization of the Iliotibial Band to Offload the Medial Condyle for Pain Relief in Patients With Medial Osteoarthritis - A Safety Study

The objective of this study is to evaluate the safety and technical feasibility of implanting the Latella Implant System in the treatment of patients with medial osteoarthritis of the knee.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of pain as due to medial osteoarthritis

Exclusion Criteria:

  • Rheumatoid arthritis
  • Joint or ligament instability
  • Metal ion allergy

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: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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
Freedom from unanticipated serious adverse device effects
Time Frame: 12 Months
12 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

November 1, 2013

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

April 1, 2017

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (ESTIMATE)

December 6, 2013

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

  • COT1-13-01
  • COTERA-1

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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