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A Study to Evaluate the Safety of Augment™ Bone Graft

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Completed
CT.gov ID
NCT01290991
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
13
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Augment Bone Graft
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee. [12 months]

      Collection of related adverse events

    Secondary Outcome Measures

    1. To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee. [12 months]

      Assess healing and bone formation from radiological reports

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen Elizabeth ll Health Sciences Centre Halifax Nova Scotia Canada B3H 3A7

    Sponsors and Collaborators

    • Nova Scotia Health Authority

    Investigators

    • Principal Investigator: William D Stanish, MD, Capital Dictrict Health Authority

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    William Stanish, Medical Doctor, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT01290991
    Other Study ID Numbers:
    • Stanish-2010-01
    First Posted:
    Feb 7, 2011
    Last Update Posted:
    Aug 21, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Cartilage Diseases

    Study Results

    No Results Posted as of Aug 21, 2012