Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction

NCT ID: NCT02608957

Last Updated: 2017-04-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Latella Knee Implant System

Group Type EXPERIMENTAL

Latella Knee Implant System

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Latella Knee Implant System

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cotera, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The George Washington University

Washington D.C., District of Columbia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIP-0002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zimmer Trabecular Metal Total Ankle PMCF
NCT02038140 ACTIVE_NOT_RECRUITING NA
Early Artificial Lateral Prosthesis
NCT06705985 NOT_YET_RECRUITING NA