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

NCT ID: NCT02002637

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Latella Knee Implant System

Group Type EXPERIMENTAL

Latella Knee Implant System

Intervention Type DEVICE

Interventions

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Latella Knee Implant System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* History of pain as due to medial osteoarthritis

Exclusion Criteria

* Rheumatoid arthritis
* Joint or ligament instability
* Metal ion allergy
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cotera, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manoj Ramachandran, MD

Role: PRINCIPAL_INVESTIGATOR

Barts & The London NHS Trust

Locations

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Slotervaart Hospital

Amsterdam, , Netherlands

Site Status

Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

Other Identifiers

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COTERA-1

Identifier Type: -

Identifier Source: secondary_id

COT1-13-01

Identifier Type: -

Identifier Source: org_study_id

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