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

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

Study Overview

• Status: Completed
• Conditions: Defect of Articular Cartilage
• Intervention / Treatment: Device: Augment Bone Graft

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Queen Elizabeth ll Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bone Graft; Single Arm.. Augment Bone Graft for Osteochondral Defects	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.; Other Names: Bone Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: William D Stanish, MD, Capital Dictrict Health Authority

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: February 2, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): August 21, 2012
• Last Update Submitted That Met QC Criteria: August 20, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases
• Other Study ID Numbers: Stanish-2010-01