Back to resultsA Study to Evaluate the Safety of Augment™ Bone Graft
Primary Purpose
Defect of Articular Cartilage
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Augment Bone Graft
Sponsored by
About this trial
This is an interventional treatment trial for Defect of Articular Cartilage
Eligibility Criteria
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.
Sites / Locations
- Queen Elizabeth ll Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Bone Graft
Arm Description
Single Arm.. Augment Bone Graft for Osteochondral Defects
Outcomes
Primary Outcome Measures
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
Collection of related adverse events
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01290991
First Posted
February 2, 2011
Last Updated
August 20, 2012
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT01290991
Brief Title
A Study to Evaluate the Safety of Augment™ Bone Graft
Official Title
A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone Graft
Arm Type
Other
Arm Description
Single Arm.. Augment Bone Graft for Osteochondral Defects
Intervention Type
Device
Intervention Name(s)
Augment Bone Graft
Other Intervention Name(s)
Bone Graft
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
Description
Collection of related adverse events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.
Description
Assess healing and bone formation from radiological reports
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Stanish, MD
Organizational Affiliation
Capital Dictrict Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth ll Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety of Augment™ Bone Graft
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