A Study to Evaluate the Safety of Augment™ Bone Graft

NCT01290991 | Completed

• 1 other identifier: Stanish-2010-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Defect of Articular Cartilage

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.

  Collection of related adverse events

  12 months

Secondary Outcomes (1)

• To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.

  12 months

Study Arms (1)

Bone Graft

OTHER

Single Arm.. Augment Bone Graft for Osteochondral Defects

Device: Augment Bone Graft

Interventions

Augment Bone Graft DEVICE

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.

Also known as: Bone Graft

Bone Graft

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth ll Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• William D Stanish, MD

  Capital Dictrict Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 7, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 21, 2012

Record last verified: 2012-08

Locations

CA (1)