A Study to Evaluate the Safety of Augment™ Bone Graft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William Stanish, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01290991
First received: February 2, 2011
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Defect of Articular Cartilage
Device: Augment Bone Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

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


Enrollment: 1
Study Start Date: July 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290991

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

No publications provided

Responsible Party: William Stanish, Medical Doctor, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01290991     History of Changes
Other Study ID Numbers: Stanish-2010-01
Study First Received: February 2, 2011
Last Updated: August 20, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 21, 2014