The Kiva® System as a Vertebral Augmentation Treatment

Spinal Fractures Clinical Trial

— KAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123512
• Other study ID #: BEN005
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2010
• Last updated: October 1, 2014
• Start date: July 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2014
• Source: Benvenue Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Ethics CommissionFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria

Patients must meet all of the following inclusion criteria below to be included as research subjects:

1. The patient is at least 50 years of age

2. 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

3. The patient has an Oswestry Disability Index (ODI) score of = 30%

4. 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

5. The patient has central pain over the spinous process(es) upon palpation at the Index level(s)

6. 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

7. The Index fracture(s) has / have failed conservative care of at least 2 weeks but no longer than 6 months

8. The Index fracture(s) shows radiographic evidence of at least 5% vertebral collapse

9. The pedicle identified for access to the index fracture has a diameter that is = 6 mm

10. 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

11. The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments

Exclusion Criteria

Patients will not be allowed to participate in the study if they meet any of the exclusion criteria below:

1. The index fracture(s) has/have been caused by high-energy trauma

2. The index fracture(s) has / have known tumor involvement

3. The index fracture(s) is/are diagnosed as an osteonecrotic fracture(s) by the treating physician

4. The Index fracture(s) is a/are translational force fracture(s) (A2.1, 2.2, 2.3)

5. 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

6. The index fracture(s) has / have posterior vertebral wall displacement occupying more than 20% of the cross sectional area of the spinal canal

7. The index fracture(s) has / have severe deformity with reduction of >75% in any height and accompanying area, using adjacent level as comparison

8. 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)

9. Angulation of index fracture(s) makes treatment with Kiva System impossible (at discretion of surgeon)

10. The pedicle identified for access to the index fracture has a diameter less than 6 mm

11. The patient has Paget's disease

12. The patient has a BMI > 35

13. The patient has uncontrolled diabetes as characterized by hemoglobin HbA1c >7% and/or blood sugar >180mg/dL

14. The patient has severe cardiopulmonary deficiencies

15. The patient has myelopathy

16. The patient is on long-term steroid therapy (steroid dose = 30 mg /day for > 3 months)

17. 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)

18. The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level(s) to be treated;

19. The patient has neurologic symptoms or deficits or radiculopathy related to the VCF

20. The patient has pain based on clinical diagnosis of herniated nucleus palposus or severe spinal stenosis (progressive weakness or paralysis)

21. 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)

22. The patient has planned spine surgery for any disorder during or up to 30 days after the study treatment

23. The patient has had spine surgery for any disorder in the 30 days prior to enrollment

24. 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

25. The patient has a known allergy to the investigational device materials and / or acrylics / polymethylmethacrylate (PMMA) or a hypersensitivity to monomers

26. The patient has been diagnosed with hemorrhagic diathesis

27. The patient has uncontrolled psychiatric illness or severe dementia

28. 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

29. The patient has a baseline Oswestry Disability Index (ODI) score of <30%

30. The patient is currently on anti-cancer therapy or anti-HIV therapy

31. Patient has autoimmune or inflammatory rheumatic disease

32. Patient's life expectancy is less than the study duration or undergoing palliative care

33. The patient is known to be a current alcohol or drug abuser

34. The patient is known to be involved in medical litigation including Workmen's Compensation

35. The patient is a prisoner

36. The patient is participating in another investigational study that has a potential for effect to the study treatment or the study endpoints

37. The patient is pregnant or considering getting pregnant during study participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Injuries
• Fractures, Bone
• Fractures, Compression
• Spinal Fractures

Intervention

Device:
• Vertebral augmentation
Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Benvenue Medical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Study Success	Patient success will be defined as: Reduction in VCF fracture-related pain at 12 months by >15 mm from baseline as measured by a 100 mm Visual Analog Scale (VAS),; Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI), and; 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	No