A Study to Evaluate the Safety of Augment™ Bone Graft

Defect of Articular Cartilage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290991
• Other study ID #: Stanish-2010-01
• Status: Completed
• Phase: N/A
• First received: February 2, 2011
• Last updated: August 20, 2012
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage

Intervention

Device:
• Augment Bone Graft
Augment Bone Graft physically fills bone defects by providing a biocompatible scaffold for new bone formation.The material is comprised of a matrix of beta tricalcium phosphate and a highly purified recombinant human platelet-derived growth factor.

Locations

Country	Name	City	State
Canada	Queen Elizabeth ll Health Sciences Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.	Collection of related adverse events	12 months	Yes
Secondary	To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.	Assess healing and bone formation from radiological reports	12 months	Yes