A Study to Evaluate the Safety of Augment™ Bone Graft

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

Detailed Description
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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.

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

Conditions
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Defect of Articular Cartilage

Intervention / Treatment
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* Device: Augment Bone Graft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bone Graft<br>Single Arm.. Augment Bone Graft for Osteochondral Defects | Device: Augment Bone Graft<br>* 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.<br>* Other names: Bone Graft;|

What is the study measuring?
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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 |