The Kiva® System as a Vertebral Augmentation Treatment

NCT01123512 | Completed Phase 3 Results

• 1 other identifier: BEN005
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 21

Brief 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.

Conditions

Spinal Fractures; Fractures, Compression; Back Injuries

Keywords

Vertebral Compression Fracture; Kyphoplasty; Spine; Vertebral Body Compression Fracture; Back Pain

Outcome Measures

Primary Outcomes (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

  12 Month Post-op

Study Arms (2)

Kiva VCF Treatment System

EXPERIMENTAL

Device: Vertebral augmentation

Balloon Kyphoplasty

ACTIVE COMPARATOR

Device: Vertebral augmentation

Interventions

Vertebral augmentation DEVICE

Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Balloon Kyphoplasty; Kiva VCF Treatment System

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

• 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

Sponsors & Collaborators

• Benvenue Medical, Inc.: lead

Study Sites (21)

CORE Orthopaedic Medical Center

Encinitas, California, 92021, United States

Location

El Camino Hospital

Mountain View, California, 94040, United States

Location

Radiological Associates of Sacramento

Sacramento, California, 95816, United States

Location

St. Mary's Spine Center

San Francisco, California, 94117, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Adventist Hospital

Hinsdale, Illinois, 60521, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Sierra Regional Spine Institute

Reno, Nevada, 89509, United States

Location

Clinical Radiology of Oklahoma

Edmond, Oklahoma, 73013, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

CHC Saint Joseph

Liège, Belgium

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

CHU Amiens Sud

Amiens, 80054, France

Location

Universitatsklinikum Bonn

Bonn, Germany

Location

Klinikum Ernst von Bergmann gGmbH

Potsdam, Germany

Location

Related Publications (1)

• 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.

  PMID: 28934783 DERIVED

MeSH Terms

Conditions

Spinal Fractures; Fractures, Compression; Back Injuries; Back Pain

Condition Hierarchy (Ancestors)

Spinal Injuries; Wounds and Injuries; Fractures, Bone; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barbara S. Lindsay, Vice President Clinical & Regulatory Affairs
• Organization: Benvenue Medical, Inc.

blindsay@benvenuemedical.com

408-454-9300

Study Officials

• Steven R. Garfin, MD

  University of California, San Diego, CA

  PRINCIPAL INVESTIGATOR

• Sean M. Tutton, MD, FSIR

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 14, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 9, 2014
• Results First Posted: August 21, 2014

Record last verified: 2014-10

Locations

CA (2); US (15); BE (1); FR (1); DE (2)