KAST: The Kiva® System as a Vertebral Augmentation Treatment

• Sponsor: Benvenue Medical, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01123512
• Collaborator: (none)
• Enrollment: 300
• Locations: 21
• Arms: 2
• Duration (Months): 34
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Fractures; Fractures, Compression; Back Injuries	Device: Vertebral augmentation	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Kiva® System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kiva VCF Treatment System	Device: Vertebral augmentation; Vertebral augmentation for one or two osteoporotic vertebral compression fractures
Active Comparator: Balloon Kyphoplasty	Device: Vertebral augmentation; Vertebral augmentation for one or two osteoporotic vertebral compression fractures

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants With Study Success [12 Month Post-op]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CORE Orthopaedic Medical Center	Encinitas	California	United States	92021
2	El Camino Hospital	Mountain View	California	United States	94040
3	Radiological Associates of Sacramento	Sacramento	California	United States	95816
4	St. Mary's Spine Center	San Francisco	California	United States	94117
5	Radiology Imaging Associates	Englewood	Colorado	United States	80112
6	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
7	Evanston Hospital	Evanston	Illinois	United States	60201
8	Adventist Hospital	Hinsdale	Illinois	United States	60521
9	Spine Institute of Louisiana	Shreveport	Louisiana	United States	71101
10	Mayo Clinic-Rochester	Rochester	Minnesota	United States	55905
11	Sierra Regional Spine Institute	Reno	Nevada	United States	89509
12	Clinical Radiology of Oklahoma	Edmond	Oklahoma	United States	73013
13	Penn State Hershey Medical Center	Hershey	Pennsylvania	United States	17033
14	Medical University of South Carolina	Charleston	South Carolina	United States	29425
15	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
16	CHC Saint Joseph	Liege		Belgium
17	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
18	Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4
19	CHU Amiens Sud	Amiens		France	80054
20	Universitatsklinikum Bonn	Bonn		Germany
21	Klinikum Ernst von Bergmann gGmbH	Potsdam		Germany

Sponsors and Collaborators

• Benvenue Medical, Inc.

Investigators

• Principal Investigator: Steven R. Garfin, MD, University of California, San Diego, CA
• Principal Investigator: Sean M. Tutton, MD, FSIR, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benvenue Medical, Inc.
• ClinicalTrials.gov Identifier: NCT01123512
• Other Study ID Numbers: BEN005
• First Posted: May 14, 2010
• Last Update Posted: Oct 9, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Benvenue Medical, Inc.: Vertebral Compression Fracture; Kyphoplasty; Spine; Vertebral Body Compression Fracture; Back Pain
• Additional relevant MeSH terms: Fractures, Bone; Spinal Fractures; Back Injuries; Fractures, Compression

Study Results

Participant Flow

Arm/Group Title	Kiva VCF Treatment System	Balloon Kyphoplasty
Arm/Group Description	The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.	The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
Period Title: Overall Study
STARTED	153	147
COMPLETED	127	126
NOT COMPLETED	26	21

Baseline Characteristics

Arm/Group Title	Kiva VCF Treatment System	Balloon Kyphoplasty	Total
Arm/Group Description	The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.	The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.	Total of all reporting groups
Overall Participants	144	141	285
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.03 (8.82)	75.09 (9.62)	75.57 (9.22)
Sex: Female, Male (Count of Participants)
Female	105 72.9%	106 75.2%	211 74%
Male	39 27.1%	35 24.8%	74 26%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With Study Success
Description	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
Time Frame	12 Month Post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Kiva VCF Treatment System	Balloon Kyphoplasty
Arm/Group Description	The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.	The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
Measure Participants	127	126
Number [participants]	120 83.3%	123 87.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Kiva VCF Treatment System, Balloon Kyphoplasty
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Pr( Pt - Pc > -12.5% | data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt - Pc > -12.5% | data)> 96.6%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	% Probability of Equivalence = 99.92
	Estimated Value	99.92
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Kiva VCF Treatment System		Balloon Kyphoplasty
Arm/Group Description	Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures		Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
All Cause Mortality
	Kiva VCF Treatment System		Balloon Kyphoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Kiva VCF Treatment System		Balloon Kyphoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/153 (28.8%)		51/147 (34.7%)
Blood and lymphatic system disorders
Anaemia	1/153 (0.7%)	1	1/147 (0.7%)	1
Plasmacytosis	1/153 (0.7%)	1	0/147 (0%)	0
Spleen disorder	1/153 (0.7%)	1	0/147 (0%)	0
Cardiac disorders
Acute coronary syndrome	0/153 (0%)	0	1/147 (0.7%)	1
Acute myocardial infarction	1/153 (0.7%)	1	0/147 (0%)	0
Arrhythmia	2/153 (1.3%)	2	0/147 (0%)	0
Atrial fibrillation	0/153 (0%)	0	1/147 (0.7%)	1
Cardiac arrest	0/153 (0%)	0	1/147 (0.7%)	1
Cardiac failure	1/153 (0.7%)	1	0/147 (0%)	0
Cardiac failure acute	1/153 (0.7%)	1	0/147 (0%)	0
Cardiac failure congestive	1/153 (0.7%)	1	2/147 (1.4%)	4
Dizziness	0/153 (0%)	0	1/147 (0.7%)	1
Myocardial infarction	0/153 (0%)	0	3/147 (2%)	3
Unstable angina	0/153 (0%)	0	1/147 (0.7%)	1
Eye disorders
Cataract	0/153 (0%)	0	1/147 (0.7%)	1
Gastrointestinal disorders
Abdominal pain	0/153 (0%)	0	1/147 (0.7%)	1
Diverticulum	1/153 (0.7%)	1	0/147 (0%)	0
Inguinal hernia	1/153 (0.7%)	1	0/147 (0%)	0
Intestinal functional disorder	0/153 (0%)	0	1/147 (0.7%)	1
Intestinal perforation	0/153 (0%)	0	1/147 (0.7%)	1
Intestinal prolapse	0/153 (0%)	0	1/147 (0.7%)	1
Mesenteric artery embolism	0/153 (0%)	0	1/147 (0.7%)	1
Pancreatitis acute	0/153 (0%)	0	1/147 (0.7%)	1
Rectal haemorrhage	1/153 (0.7%)	2	0/147 (0%)	0
Subileus	0/153 (0%)	0	1/147 (0.7%)	1
Vomiting	0/153 (0%)	0	1/147 (0.7%)	1
General disorders
Chest pain	2/153 (1.3%)	2	1/147 (0.7%)	2
Hepatobiliary disorders
Cholecystitis acute	0/153 (0%)	0	1/147 (0.7%)	1
Cholelithiasis	1/153 (0.7%)	1	1/147 (0.7%)	1
Infections and infestations
Abscess	1/153 (0.7%)	1	0/147 (0%)	0
Bronchitis	1/153 (0.7%)	1	0/147 (0%)	0
Cytomegalovirus colitis	1/153 (0.7%)	1	0/147 (0%)	0
Infection	1/153 (0.7%)	1	0/147 (0%)	0
Influenza	0/153 (0%)	0	1/147 (0.7%)	1
Intervertebral discitis	0/153 (0%)	0	1/147 (0.7%)	1
Peridiverticulitis	1/153 (0.7%)	2	0/147 (0%)	0
Pneumonia	5/153 (3.3%)	5	3/147 (2%)	3
Post procedural infection	1/153 (0.7%)	2	0/147 (0%)	0
Pseudomembranous colitis	1/153 (0.7%)	1	0/147 (0%)	0
Respiratory tract infection	1/153 (0.7%)	1	0/147 (0%)	0
Sepsis	1/153 (0.7%)	1	2/147 (1.4%)	2
Urinary tract infection	2/153 (1.3%)	2	4/147 (2.7%)	4
Injury, poisoning and procedural complications
Airway complication of anesthesia	0/153 (0%)	0	1/147 (0.7%)	1
Cervical vertebral fracture	1/153 (0.7%)	1	0/147 (0%)	0
Fall	2/153 (1.3%)	2	3/147 (2%)	5
Femoral neck fracture	1/153 (0.7%)	1	0/147 (0%)	0
Femur fracture	1/153 (0.7%)	1	1/147 (0.7%)	1
Fracture	1/153 (0.7%)	1	0/147 (0%)	0
Hip fracture	1/153 (0.7%)	1	1/147 (0.7%)	1
Muscle injury	0/153 (0%)	0	1/147 (0.7%)	1
Pelvic fracture	1/153 (0.7%)	1	1/147 (0.7%)	1
Rib fracture	0/153 (0%)	0	1/147 (0.7%)	1
Spinal compression fracture	10/153 (6.5%)	14	13/147 (8.8%)	20
Wrist fracture	1/153 (0.7%)	1	0/147 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/153 (0%)	0	1/147 (0.7%)	1
Electrolyte imbalance	0/153 (0%)	0	2/147 (1.4%)	2
Failure to thrive	0/153 (0%)	0	1/147 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/153 (0.7%)	1	0/147 (0%)	0
Back pain	4/153 (2.6%)	4	3/147 (2%)	4
Intervertebral disc disorder	0/153 (0%)	0	1/147 (0.7%)	1
Muscle spasms	1/153 (0.7%)	1	1/147 (0.7%)	1
Osteoarthritis	0/153 (0%)	0	1/147 (0.7%)	1
Soft tissue necrosis	1/153 (0.7%)	1	0/147 (0%)	0
Spinal column stenosis	1/153 (0.7%)	1	1/147 (0.7%)	2
Spondylolysis	1/153 (0.7%)	1	0/147 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/153 (0.7%)	1	1/147 (0.7%)	1
Lung cancer metas	1/153 (0.7%)	1	0/147 (0%)	0
Multiple myeloma	0/153 (0%)	0	1/147 (0.7%)	1
Myelodysplastics	1/153 (0.7%)	2	1/147 (0.7%)	1
Plasmacytoma	0/153 (0%)	0	1/147 (0.7%)	1
Spinal menigioma	1/153 (0.7%)	1	0/147 (0%)	0
Nervous system disorders
Ischaemic stroke	0/153 (0%)	0	2/147 (1.4%)	2
Myasthenia gravis	0/153 (0%)	0	1/147 (0.7%)	1
Presyncope	0/153 (0%)	0	1/147 (0.7%)	1
Syncope	0/153 (0%)	0	2/147 (1.4%)	2
Psychiatric disorders
Bipolar disorder	1/153 (0.7%)	1	0/147 (0%)	0
Confusional state	0/153 (0%)	0	1/147 (0.7%)	1
Fear of falling	0/153 (0%)	0	1/147 (0.7%)	1
Major depression	1/153 (0.7%)	1	0/147 (0%)	0
Pseudodementia	0/153 (0%)	0	1/147 (0.7%)	1
Suicide attempt	2/153 (1.3%)	2	0/147 (0%)	0
Renal and urinary disorders
renal disorder	0/153 (0%)	0	1/147 (0.7%)	1
Renal mass	0/153 (0%)	0	1/147 (0.7%)	1
Reproductive system and breast disorders
Pelvic pain	0/153 (0%)	0	1/147 (0.7%)	1
Vaginal prolapse	0/153 (0%)	0	1/147 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	2/153 (1.3%)	3	2/147 (1.4%)	2
Haemoptysis	1/153 (0.7%)	1	0/147 (0%)	0
Pneumonia aspiration	0/153 (0%)	0	2/147 (1.4%)	2
Pulmonary embolism	1/153 (0.7%)	1	1/147 (0.7%)	1
Pulmonary oedema	2/153 (1.3%)	2	1/147 (0.7%)	1
Respiratory failure	1/153 (0.7%)	1	1/147 (0.7%)	1
Skin and subcutaneous tissue disorders
Rash	0/153 (0%)	0	1/147 (0.7%)	1
Surgical and medical procedures
Bladder catheter replacement	0/153 (0%)	0	1/147 (0.7%)	1
Drug delivery device implantation	1/153 (0.7%)	1	0/147 (0%)	0
Subdural haematoma evacuation	0/153 (0%)	0	1/147 (0.7%)	1
Vascular disorders
Aortic aneurysm	0/153 (0%)	0	1/147 (0.7%)	1
Aortic stenosis	0/153 (0%)	0	1/147 (0.7%)	1
Deep vein thrombosis	0/153 (0%)	0	1/147 (0.7%)	1
Hypertension	0/153 (0%)	0	1/147 (0.7%)	1
Hypotension	0/153 (0%)	0	2/147 (1.4%)	2
Intermittent claudication	0/153 (0%)	0	1/147 (0.7%)	2
Peripheral vascular disorder	0/153 (0%)	0	1/147 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Kiva VCF Treatment System		Balloon Kyphoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/153 (52.9%)		80/147 (54.4%)
General disorders
Oedema peripheral	3/153 (2%)	3	2/147 (1.4%)	2
Pain	1/153 (0.7%)	1	3/147 (2%)	3
Infections and infestations
Herpes zoster	3/153 (2%)	3	1/147 (0.7%)	1
Urinary tract infection	3/153 (2%)	3	1/147 (0.7%)	1
Injury, poisoning and procedural complications
Fall	4/153 (2.6%)	4	2/147 (1.4%)	4
Rib fracture	0/153 (0%)	0	3/147 (2%)	3
Spinal compression fracture	49/153 (32%)	74	40/147 (27.2%)	58
Musculoskeletal and connective tissue disorders
Arthralgia	2/153 (1.3%)	2	4/147 (2.7%)	4
Back pain	39/153 (25.5%)	52	41/147 (27.9%)	45
Nervous system disorders
Motor dysfunction	0/153 (0%)	0	3/147 (2%)	3
Reflexes abnormal	7/153 (4.6%)	8	3/147 (2%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnoea	3/153 (2%)	3	0/147 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.