A Study to Evaluate the Safety of Augment™ Bone Graft | NCT01290991

Studies
A Study to Evaluate the Safety of Augment™ Bone Graft

NCT01290991

Sponsor

Nova Scotia Health Authority

Status

Completed

Last Update Posted

Aug 21, 2012Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Defect of Articular Cartilage

Interventions

Augment Bone Graft

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Feb 2, 2011

First Submission Date that Met QC Criteria

Feb 4, 2011

First Posted Date

Feb 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bone Graft	Other	Single Arm.. Augment Bone Graft for Osteochondral Defects	Device: Augment Bone Graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.	Assess healing and bone formation from radiological reports	12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics