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Degenerative Disc DiseasePhase 1/2NCT00798902

Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery

A Phase 1/2 study testing Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules and Iliac crest autograft in people with Degenerative Disc Disease and Spondylolisthesis, run by BioSurface Engineering Technologies, Inc at 6 sites in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Degenerative Disc Disease, Spondylolisthesis
What is being tested?
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules and Iliac crest autograft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
6 sitesUnited States
Study dates
Nov 2008to Oct 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented diagnosis of DDD requiring single level fusion (L2-S1) with up to Grade I Spondylolisthesis
  • Have a preoperative screening qualifying VAS and ODI scores
  • Be a skeletally mature male or a non-pregnant, non-lactating female, age 18 -70 inclusive
  • Have not been sufficiently responsive to at least 6 months of non-operative treatment prior to study enrollment

Who cannot join

  • Are female subjects who are pregnant or nursing, or women planning to become pregnant during the first year (12 months) following the surgery
  • A history of previous surgery in the lumbar spine with or without attempted fusion
  • Grade II or greater spondylolisthesis
  • More than 0 degrees of kyphosis at the operated disc space
  • Evidence of scoliosis in the lumbar region of more than 10 degrees
  • Collapsed disc space with bridging osteophytes
Show all 27Show fewer
  • A systemic or local infection at the site of surgery
  • An acute fracture of the spine at the time of enrollment in the study
  • An active history of systemic malignancy
  • A medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study
  • A known hypersensitivity to any of the components of the product or a known titanium allergy or a known allergy to polyetheretherketone (PEEK)
  • A history of any autoimmune disease, such as, systemic lupus erythematosus, Addison's disease, Crohn's disease, or rheumatoid arthritis
  • A history of any severe allergy or anaphylaxis, or a history of hypersensitivity to protein pharmaceuticals, or have had any previous exposure to a protein pharmaceutical
  • Are receiving treatment (before or during surgery) with a drug (e.g., steroids, methotrexate, etc.) that interferes with bone metabolism or are being treated with a bone growth stimulator
  • A medical condition requiring radiation, chemotherapy or immunosuppression, or a medical condition requiring systemic corticosteroids
  • Are covered under workmen's compensation insurance or prisoners
  • Are transient or have been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-subject substance abuse program
  • Have participated in clinical studies within 3 months of enrollment
  • Have a body mass index (BMI) greater than 35
  • Use tobacco products (also includes, e.g. nicotine patch or nicotine gum), or have smoked cigarettes within 6 weeks preceding enrollment
  • Known to require additional surgery to the lumbar spinal region within the next 6 months
  • Have symptomatic multilevel degenerative disease requiring possible instrumented fusion of more than one vertebral level
  • 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 or radiographic evidence of a metabolic bone disease (e.g., osteoporosis or osteopenia) or other condition which would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving pedicle screw fixation
  • Are involved in or planning to engage in litigation related to back and/or leg pain
  • Require chronic SQ or IV heparin therapies
  • Have an Osteoporosis Risk Assessment Instrument (ORAI) score > to 9 points and, if so, will require a qualifying DEXA scan T score

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Confidential

    Durango, Colorado, 81301

  • Confidential

    Jefferson City, Missouri, 65101

  • Confidential

    Johnson City, New York, 13790

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Confidential

    Tyler, Texas, 75701

  • Confidential

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: A Multi-Center, Prospective, Parallel Group, Randomized, Pilot Study Evaluating Safety and Preliminary Effectiveness Of Prefix Compared To Iliac Crest Bone In Subjects With DDD Undergoing Transforaminal Lumbar Interbody Fusion

This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from L2-S1.

Being tested
Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
Keywords
DDD, Spondylolisthesis, Spine Fusion, Lumbar Spine, Bone Graft
Medical subject headings
Intervertebral Disc Degeneration, Spondylolisthesis

What participants receive

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

  • Prefix (AMPLEX) B2A Peptide Enhanced Ceramic GranulesDevice

    Also called AMPLEX

    150 micrograms/cc BVF

  • Iliac crest autograftOther

    autograft

Study groups in NCT00798902
Study groupRoleWhat they receive
ControlActive comparatorIliac Crest Autograft
Receives: Other: Iliac crest autograft
Prefix 150ExperimentalPrefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules
Receives: Device: Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules

What is being measured

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

  1. Removal/revision or supplemental fixation of the graft material requiring reoperation at the index level, Safety (adverse events), Fusion "success" based on X-rays, Change from baseline in neurological exam scores and ODI scores

    Measured: 12 months post surgery

Secondary outcomes (1)

  1. Volume of blood loss/transfused blood during surgery, Blinded independent assessment of fusion by CT and other radiographic assessments, Change from baseline in pain scores using VAS and change from baseline in SF-36 v2™ total and subscale scores

    Measured: 12 months post surgery

Timeline

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

  1. First posted26 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJul 2012 (estimated)
  4. Study completionOct 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
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00798902
Sponsor's protocol ID
PFX-100
Status last verified
Mar 2012
First submitted
24 Nov 2008
Last updated
9 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules and Iliac crest autograft in people with Degenerative Disc Disease and Spondylolisthesis, run by BioSurface Engineering Technologies, Inc at 6 sites in United States.

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 4 inclusion and 27 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 6 sites in United States. 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?

Removal/revision or supplemental fixation of the graft material requiring reoperation at the index level, Safety (adverse events), Fusion "success" based on X-rays, Change from baseline in neurological exam scores and ODI scores (time frame: 12 months post surgery). 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 NCT00798902.

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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