A Study to Evaluate the Safety of Augment™ Bone Graft

Not Applicable

Completed

• Conditions: Defect of Articular Cartilage

• Registration Number: NCT01290991
• Lead Sponsor: Nova Scotia Health Authority

Brief 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.

Study Timeline

• Study First Submitted: 2011-02-02
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Study Start: 2011-07
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-20
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.
• Subject must present with pain > 3.0 cm according to the Visual Analogue Score.
• Subject has exhausted non operative treatment.

Exclusion:

• Allergy to yeast derived products.
• Index knee has had cartilage repair in the last six months.
• Subjects with osteoarthritis,inflammatory arthritis, rheumatoid arthritis and avascular necrosis of index knee.
• Subject has contralateral knee complications which would interfere with rehabilitation
• Subject has implanted metallic devices that would prevent Magnetic Resonance Imaging (MRI).
• Subject has claustrophobia that would prevent MRI.
• Subject has had a malignancy or is being treated for a malignancy.
• Subject is physically or mentally compromised that would interfere with compliance.
• Subject is a prisoner or transient.
• Subject has a recent history (12 months) of alcohol abuse.
• Subject is pregnant, able to become pregnant but not practising birth control.
• Subject has an infection in the operative area.
• Subject has scheduled surgery on the contralateral knee over the course of the study.
• Subject requires another procedure in the index knee.
• Subject has had steroid therapy in the past six months.
• Subject is taking prescription pain medication for another indication other than the index knee.
• Subject is using nicotine in any form.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.	12 months	Collection of related adverse events

Secondary Outcome Measures

Name	Time	Method
To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.	12 months	Assess healing and bone formation from radiological reports

Trial Locations

Locations (1)

Queen Elizabeth ll Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada