Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2011-07-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bone Graft
Single Arm.. Augment Bone Graft for Osteochondral Defects
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
40 Years
ALL
No
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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William Stanish
Medical Doctor
Principal Investigators
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William D Stanish, MD
Role: PRINCIPAL_INVESTIGATOR
Capital Dictrict Health Authority
Locations
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Queen Elizabeth ll Health Sciences Centre
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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Stanish-2010-01
Identifier Type: -
Identifier Source: org_study_id