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ArthritisPhase 1/2NCT01224119

A Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery

A Phase 1/2 study testing Amplex and Autograft bone in people with Arthritis, run by BioSurface Engineering Technologies, Inc at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material. The most frequently used graft material is bone collected from the patient (autograft). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis
What is being tested?
Amplex and Autograft bone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
Jan 2011to Apr 2012
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Indicated for foot and ankle surgery described as either a single, double or triple arthrodesis of the ankle, subtalar, calcaneocuboid or talonavicular joints.
  • Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
  • Have the ability to understand and provide written authorization for the use and disclosure of personal health information (PHI)
  • Be a skeletally mature male or a non-pregnant, non-lactating female at least 18 years of age but not older than age 75
  • If a woman is of childbearing potential (not amenorrheic for the previous 24 months or not surgically sterile), then she must:
  • Have a confirmed negative urine pregnancy test result prior to surgery and the administration of the study product
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  • Agree to use a medically approved method of contraception for the duration of the initial follow-up period of the study
  • Agree to participate in postoperative clinical and radiographic evaluations and comply with the required study regimen
  • Have not been sufficiently responsive to an adequate trial of non-operative treatment (e.g. modified activity, analgesics, anti-inflammatories, bracing, orthotics, physiotherapy, vitamin supplements, or injections etc. prior to study enrollment).

Who cannot join

  • Has a large bone deficit requiring a structural graft
  • Charcot joints from neuropathic destruction.
  • Previous fusion or osteotomy of the proposed site
  • Requires osteotomy or fusion of the midfoot joints
  • Morbidly obese (BMI >45 kg/m2)
  • Women planning to become pregnant during the first year (12 months) following the procedure
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  • Female subjects of childbearing potential unwilling to use medically acceptable contraceptive methods (e.g., surgical sterilization, hormonal contraceptives, barrier methods, or intrauterine devices) so as to prevent pregnancy for 12 months following the study procedure
  • Have at the time of surgery a systemic infection or local infection at the site of surgery
  • Have an active history of systemic malignancy.
  • Currently has untreated malignant neoplasm(s), or is currently undergoing radio- or chemotherapy or has been diagnosed with hypercalcemia.
  • Have a medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., histories of transient ischemic attack, stroke or liver disease)
  • Has a known complication of diabetes (e.g. retinopathy, renal failure, neuropathic complication in lower limb).
  • Uncontrolled diabetes. If the patient has been diagnosed with diabetes, they must have an Hgb A1C level less than 7 to participate.
  • Have a known hypersensitivity to any of the components of the product [e.g., Hydroxyapatite (HA): Tricalcium Phosphate (TCP) ceramic granule] or a known titanium allergy
  • Receiving active treatment with a drug known to interfere with bone metabolism (e.g. long-term steroid therapy, methotrexate).
  • Have a history of any severe allergy or anaphylaxis, or a history of hypersensitivity to protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins, recombinant BMPs)
  • Being treated with a bone growth stimulator
  • Have a medical condition requiring radiation, chemotherapy or immunosuppression.
  • Have obvious and/or documented alcohol or illicit drug addictions
  • Are prisoners
  • Have participated in clinical studies evaluating investigational devices, pharmaceuticals or biologics within 3 months of enrollment
  • Have previously been treated with, or exposed to, therapeutic levels of Bone Morphogenetic Proteins (BMPs), i.e., synthetic or recombinant
  • Have a documented medical history of or radiographic evidence of a metabolic bone disease (e.g., avascular necrosis, osteoporosis or osteopenia) or other condition that would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving screw fixation.
  • Require chronic SQ or IV heparin therapies

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Dr. Mark Glazebrook

    Halifax, Nova Scotia

Other trials in Canada

About this study

Official title: A Multi-Center, Randomized, Pilot Study Evaluating Amplex Compared To Autograft Bone In Foot and Ankle Fusion Surgery

The current research study evaluates an investigational medical device called Amplex B2A(TM) Peptide Enhanced Ceramic Granules ("Amplex") for use in foot and ankle fusion. Amplex is a synthetic bone graft material. The most frequently used graft material is bone collected from the patient (autograft). Autograft involves a secondary incision with the risks of infection and lasting pain.

The purpose of this study is to determine if Amplex is a safe and effective alternative to autograft.

Conditions
Arthritis
Being tested
Amplex, Autograft bone
Keywords
foot ankle arthritis bone graft
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmplexDevice

    225 micrograms of B2A per cc of ceramic granules

  • Autograft boneProcedure or surgery

    Bone is collected through a separate incision at the iliac crest or tibia.

Study groups in NCT01224119
Study groupRoleWhat they receive
Amplex (synthetic bone graft)ExperimentalNot described
Receives: Device: Amplex
Autograft boneActive comparatorNot described
Receives: Procedure: Autograft bone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic fusion

    An independent radiologist will assess radiographic fusion based upon CT imaging.

    Measured: 6 months

  2. Ankle Osteoarthritis Questionnaire

    This is a questionnaire completed by the subject. It consists of a number of questions concerning the amount of pain in the foot and its effect on functional activities.

    Measured: 6 months

Secondary outcomes (3)

  1. Ankle Osteoarthritis Questionnaire

    The is a questionnaire completed by the subject. Its asks a series of questions about pain and function of the treated foot or ankle.

    Measured: 12 months

  2. Radiographic fusion

    Radiographic fusion will be assess by a blinded indpenendent radiologists, using CT and X-ray images. The investigator will also assess fusion based on the images and also the overall condition of the subject.

    Measured: 9-12 months

  3. Various blood tests

    Small amounts of blood will be collected at study visits to identify possible changes in blood chemistry, liver function and antibody formation.

    Measured: PreOp through 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionApr 2012 (estimated)
  4. Study completionApr 2012 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01224119
Sponsor's protocol ID
AMX-200
Status last verified
Mar 2012
First submitted
18 Oct 2010
Last updated
9 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Glazebrook M, Younger A, Wing K, Lalonde KA. A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis. Foot Ankle Int. 2013 Aug;34(8):1055-63. doi: 10.1177/1071100713481459. Epub 2013 Mar 5.

    PubMed 23463779

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Amplex and Autograft bone in people with Arthritis, run by BioSurface Engineering Technologies, Inc 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 9 Mar 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Radiographic fusion (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224119, which also lists 1 linked publication.

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 9 Mar 2012.

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