A Study to Evaluate the Safety of Augment™ Bone Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01290991
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : August 21, 2012
Information provided by (Responsible Party):
William Stanish, Capital District Health Authority, Canada

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
Defect of Articular Cartilage Device: Augment Bone Graft Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1 participants
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 : July 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Arm Intervention/treatment
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 Name: Bone Graft

Primary Outcome Measures :
  1. To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee. [ Time Frame: 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. [ Time Frame: 12 months ]
    Assess healing and bone formation from radiological reports

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01290991

Canada, Nova Scotia
Queen Elizabeth ll Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Nova Scotia Health Authority
Principal Investigator: William D Stanish, MD Capital Dictrict Health Authority

Responsible Party: William Stanish, Medical Doctor, Capital District Health Authority, Canada Identifier: NCT01290991     History of Changes
Other Study ID Numbers: Stanish-2010-01
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases