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A Study to Evaluate the Safety of Augment™ Bone Graft | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety of Augment™ Bone Graft

A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee

NCT01290991•Nova Scotia Health Authority

View on ClinicalTrials.gov

Summary

Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?

Detailed Description

Subjects will be 18 to 40 years with an osteochondral defects of the knee.They will be candidates for allograft and Augment Bone Graft will be added to the procedure. The safety of Augment Bone Graft plus allograft for osteochondral defects of the knee will be evaluated by type, frequency, severity and relatedness of adverse events to the device for a minimum of 24 weeks.Magnetic Resonance Imaging will be performed at 1,12 and 42 weeks to evaluate device integrity and surgical treatment of osteochondral defects. Computed tomography will be done at week 1 and week 24 to determine the healing status of the osteochondral defect.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prior Magnetic Resonance Imaging (MRI) evaluation or MRI on Screening.
•Subjects with Grade III osteochondral defect (OCD) of femoral condyle.
•Subjects with OCD \> 1 cm.squared.
•Independent and ambulatory pts.
•Subjects from 18 to 40 years of age.
•Subject with a stable knee joint and similar stability on the opposite knee.
•Subject has knee x-ray with \< 15 degrees of valgus and \< 5 degrees varus.
•No deformity from previous fractures of tibia or fibula.
•BMI \< 35.
•Subject has an American Association of Anaesthetists physical status classification of 1 or 2.
+20 more criteria

Locations (1)

Queen Elizabeth ll Health Sciences Centre

Halifax, Nova Scotia, Canada

Key Dates

Start Date

July 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

August 21, 2012

Enrollment

ACTUAL participants

Conditions

Defect of Articular Cartilage

Interventions

Augment Bone Graft

DEVICE

Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration

NCT00881023

Defect of Articular CartilageOsteochondritis Dissecans

View study

UNKNOWNPHASE1

Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects

NCT00885729

Defect of Articular Cartilage

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety of Augment™ Bone Graft

Inclusion Criteria

Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration

Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects

Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle

the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee