The Kiva® System as a Vertebral Augmentation Treatment

Completed · Phase 3

Conditions studied: Spinal Fractures, Fractures, Compression, Back Injuries

In brief

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.

Key facts

Study ID

NCT01123512

Run by

Benvenue Medical, Inc.

People needed

300

Starts

2010-07-01

Expected to finish

2013-05-01

Last updated by the study team

2014-10-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• 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
• 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

Where it is running

• CORE Orthopaedic Medical Center — Encinitas, California, United States
• El Camino Hospital — Mountain View, California, United States
• Radiological Associates of Sacramento — Sacramento, California, United States
• St. Mary's Spine Center — San Francisco, California, United States
• Radiology Imaging Associates — Englewood, Colorado, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• Evanston Hospital — Evanston, Illinois, United States
• Adventist Hospital — Hinsdale, Illinois, United States
• Spine Institute of Louisiana — Shreveport, Louisiana, United States
• Mayo Clinic-Rochester — Rochester, Minnesota, United States
• Sierra Regional Spine Institute — Reno, Nevada, United States
• Clinical Radiology of Oklahoma — Edmond, Oklahoma, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• CHC Saint Joseph — Liège, Belgium
• Toronto Western Hospital — Toronto, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada
• CHU Amiens Sud — Amiens, France
• Universitatsklinikum Bonn — Bonn, Germany
• Klinikum Ernst von Bergmann gGmbH — Potsdam, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.