Clinical trial NCT01290991: 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
Overall status: COMPLETED
Phase: NA
Conditions: Defect of Articular Cartilage
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-02-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
timeFrame: 12 months
Secondary outcomes:
measure: To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth ll Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Dictrict Health Authority
name: William D Stanish, MD
role: PRINCIPAL_INVESTIGATOR
References: