Defect of Articular CartilageNCT01290991
A Study to Evaluate the Safety of Augment™ Bone Graft
A study testing Augment Bone Graft in people with Defect of Articular Cartilage, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee? Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Defect of Articular Cartilage
- What is being tested?
- Augment Bone Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth ll Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee
Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects of the knee?
Read the 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.
- Conditions
- Defect of Articular Cartilage
- Being tested
- Augment Bone Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augment Bone GraftDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Bone Graft | Other | Single Arm.. Augment Bone Graft for Osteochondral Defects Receives: Device: Augment Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee.
Collection of related adverse events
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Stanish, Nova Scotia Health Authority
- Investigators
- William D Stanish, MD, Principal investigator, Capital Dictrict Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290991
- Sponsor's protocol ID
- Stanish-2010-01
- Status last verified
- Aug 2012
- First submitted
- 2 Feb 2011
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Augment™ Bone Graft Plus Evaluate the Safety of Allograft for Treatment of Osteochondral Defects (OCD) of the Knee
- ClinicalTrials.gov ID
- NCT01290991
- Acronym / sponsor ID
- Stanish-2010-01
- Conditions
- Defect of Articular Cartilage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone Graft | Other | Device: Augment Bone GraftSingle Arm.. Augment Bone Graft for Osteochondral Defects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augment Bone GraftAlso: Bone GraftAugment 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. | Device | Bone Graft |
Primary outcome
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
1 secondary outcome
To utilize Magnetic Resonance Imaging to evaluate device integrity and surgical treatment of osteochondral defects of the knee.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William D Stanish, MD principal investigator
Capital Dictrict Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment Bone Graft in people with Defect of Articular Cartilage, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of Augment Bone Graft plus Allograft for treatment of osteochondral defects of the knee. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012.