AzTrials
AzTrials

Spinal FracturesPhase 3KASTNCT01123512

The Kiva® System as a Vertebral Augmentation Treatment

A Phase 3 study testing Vertebral augmentation in people with Spinal Fractures and Fractures, Compression, run by Benvenue Medical, Inc. at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Vertebral augmentation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
21 sitesin 5 countries
Study dates
Jul 2010to May 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following inclusion criteria below to be included as research subjects:
  • The patient is at least 50 years of age
  • The patient has a score on the back pain visual analog scale (VAS) of ≥70 mm after 2 to 6 weeks of conservative care OR a VAS of ≥ 50 mm after 6 weeks of conservative care
  • The patient has an Oswestry Disability Index (ODI) score of ≥ 30%
  • The patient has radiographic evidence of one or two (1-2) A 1.1, A 1.2, A 1.3. fractures as classified by the AO Spine Fracture classification, due to primary or secondary osteoporosis in the thoracic and / or lumbar spine. Note that patients are eligible if they have had treatment of or healed VCF(s) at any non-index level
  • The patient has central pain over the spinous process(es) upon palpation at the Index level(s)
Show all 12Show fewer
  • The Index fracture(s) is / are acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI
  • The Index fracture(s) has / have failed conservative care of at least 2 weeks but no longer than 6 months
  • The Index fracture(s) shows radiographic evidence of at least 5% vertebral collapse
  • The pedicle identified for access to the index fracture has a diameter that is ≥ 6 mm
  • The patient is mentally capable and willing to sign a study-specific informed consent as documentation of the informed consent process prior to any study procedures
  • The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments

Who cannot join

  • Patients will not be allowed to participate in the study if they meet any of the exclusion criteria below:
  • The index fracture(s) has/have been caused by high-energy trauma
  • The index fracture(s) has / have known tumor involvement
  • The index fracture(s) is/are diagnosed as an osteonecrotic fracture(s) by the treating physician
  • The Index fracture(s) is a/are translational force fracture(s) (A2.1, 2.2, 2.3)
  • The index fracture(s) is a/are burst fracture(s) (A 3.3., B or C type) or pedicle fracture(s) with posterior cortical wall disruption
Show all 38Show fewer
  • The index fracture(s) has / have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal
  • The index fracture(s) has / have severe deformity with reduction of >75% in any height and accompanying area, using adjacent level as comparison
  • The index level(s) has / have undergone previous surgical treatment for a vertebral body compression fracture or other surgical procedure at the index level(s)
  • Angulation of index fracture(s) makes treatment with Kiva System impossible (at discretion of surgeon)
  • The pedicle identified for access to the index fracture has a diameter less than 6 mm
  • The patient has Paget's disease
  • The patient has a BMI > 35
  • The patient has uncontrolled diabetes as characterized by hemoglobin HbA1c >7% and/or blood sugar >180mg/dL
  • The patient has severe cardiopulmonary deficiencies
  • The patient has myelopathy
  • The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
  • A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy (with a threshold for normal being INR ≤ 1.5, PTT within lab normal range, and platelet count > 100,000)
  • The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated;
  • The patient has neurologic symptoms or deficits or radiculopathy related to the VCF
  • The patient has pain based on clinical diagnosis of herniated nucleus palposus or severe spinal stenosis (progressive weakness or paralysis)
  • The patient has indications of instability related to the index fracture (≥ 30 degrees of kyphosis, translation >4mm, interspinous process widening, > Grade 1 spondylolisthesis and/or > 25 degrees of scoliosis if the index level is included in the curve)
  • The patient has planned spine surgery for any disorder during or up to 30 days after the study treatment
  • The patient has had spine surgery for any disorder in the 30 days prior to enrollment
  • The patient has a documented active systemic or local infection, such as osteomyelitis or discitis, with a WBC > 15.0 x 10^3/µL and a temperature > 101.5°F
  • The patient has a known allergy to the investigational device materials and / or acrylics / polymethylmethacrylate (PMMA) or a hypersensitivity to monomers
  • The patient has been diagnosed with hemorrhagic diathesis
  • The patient has uncontrolled psychiatric illness or severe dementia
  • The patient has a baseline back pain visual analog scale (VAS) of <50 mm if patient has at least 6 weeks of conservative care or <70 mm if patient has 2-6 weeks conservative care
  • The patient has a baseline Oswestry Disability Index (ODI) score of <30%
  • The patient is currently on anti-cancer therapy or anti-HIV therapy
  • Patient has autoimmune or inflammatory rheumatic disease
  • Patient's life expectancy is less than the study duration or undergoing palliative care
  • The patient is known to be a current alcohol or drug abuser
  • The patient is known to be involved in medical litigation including Workmen's Compensation
  • The patient is a prisoner
  • The patient is participating in another investigational study that has a potential for effect to the study treatment or the study endpoints
  • The patient is pregnant or considering getting pregnant during study participation

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States15 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Clinical Radiology of Oklahoma

    Edmond, Oklahoma, 73013

  • CORE Orthopaedic Medical Center

    Encinitas, California, 92021

  • Radiology Imaging Associates

    Englewood, Colorado, 80112

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Adventist Hospital

    Hinsdale, Illinois, 60521

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • El Camino Hospital

    Mountain View, California, 94040

  • Sierra Regional Spine Institute

    Reno, Nevada, 89509

  • Mayo Clinic-Rochester

    Rochester, Minnesota, 55905

  • Radiological Associates of Sacramento

    Sacramento, California, 95816

  • St. Mary's Spine Center

    San Francisco, California, 94117

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101

Other trials in United States

Canada2 sites

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Germany2 sites

  • Universitatsklinikum Bonn

    Bonn

  • Klinikum Ernst von Bergmann gGmbH

    Potsdam

Other trials in Germany

Belgium1 site

  • CHC Saint Joseph

    Liège

Other trials in Belgium

France1 site

  • CHU Amiens Sud

    Amiens, 80054

Other trials in France

About this study

Official title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial

The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or lumbar spine.

Being tested
Vertebral augmentation
Keywords
Vertebral Compression Fracture, Kyphoplasty, Spine, Vertebral Body Compression Fracture, Back Pain
Medical subject headings
Spinal Fractures, Fractures, Compression, Back Injuries, Back Pain

What participants receive

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

  • Vertebral augmentationDevice

    Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Study groups in NCT01123512
Study groupRoleWhat they receive
Kiva VCF Treatment SystemExperimentalNot described
Receives: Device: Vertebral augmentation
Balloon KyphoplastyActive comparatorNot described
Receives: Device: Vertebral augmentation

What is being measured

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

  1. Proportion of Participants With Study Success

    Patient success will be defined as:

    1. Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),
    2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and
    3. Absence of device-related serious adverse events, defined as device-related adverse events requiring surgical reintervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation

    Measured: 12 Month Post-op

Timeline

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

  1. First posted14 May 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01123512
Sponsor's protocol ID
BEN005
Acronym
KAST
Status last verified
Oct 2014
First submitted
11 May 2010
Last updated
9 Oct 2014
Data monitoring committee
No

Publications

  • Beall DP, Coe JD, McIlduff M, Bloch D, Hornberger J, Warner C, Tutton S. Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty. Pain Physician. 2017 Sep;20(6):521-528.

    PubMed 28934783

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vertebral augmentation in people with Spinal Fractures and Fractures, Compression, run by Benvenue Medical, Inc. at 21 sites in 5 countries.

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 38 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 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada, Germany, Belgium, France. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Participants With Study Success (time frame: 12 Month Post-op). 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 NCT01123512, 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 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in