Trial Outcomes & Findings for The Kiva® System as a Vertebral Augmentation Treatment (NCT NCT01123512)
NCT ID: NCT01123512
Last Updated: 2014-10-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
12 Month Post-op
Results posted on
2014-10-09
Participant Flow
Participant milestones
| Measure |
Kiva VCF Treatment System
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.
|
Balloon Kyphoplasty
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.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
147
|
|
Overall Study
COMPLETED
|
127
|
126
|
|
Overall Study
NOT COMPLETED
|
26
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Kiva® System as a Vertebral Augmentation Treatment
Baseline characteristics by cohort
| Measure |
Kiva VCF Treatment System
n=144 Participants
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.
|
Balloon Kyphoplasty
n=141 Participants
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
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.03 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
75.09 years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
75.57 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Month Post-opPatient 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
Outcome measures
| Measure |
Kiva VCF Treatment System
n=127 Participants
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.
|
Balloon Kyphoplasty
n=126 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Study Success
|
120 participants
|
123 participants
|
Adverse Events
Kiva VCF Treatment System
Serious events: 44 serious events
Other events: 81 other events
Deaths: 0 deaths
Balloon Kyphoplasty
Serious events: 51 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Kiva VCF Treatment System
n=153 participants at risk
Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
|
Balloon Kyphoplasty
n=147 participants at risk
Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Blood and lymphatic system disorders
Plasmacytosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Cardiac disorders
Arrhythmia
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Cardiac disorders
Cardiac failure
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Cardiac disorders
Cardiac failure acute
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
1/153 • Number of events 1
|
1.4%
2/147 • Number of events 4
|
|
Cardiac disorders
Dizziness
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/153
|
2.0%
3/147 • Number of events 3
|
|
Cardiac disorders
Unstable angina
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.65%
1/153 • Number of events 2
|
0.00%
0/147
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
General disorders
Chest pain
|
1.3%
2/153 • Number of events 2
|
0.68%
1/147 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Infections and infestations
Abscess
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Bronchitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Influenza
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Infections and infestations
Peridiverticulitis
|
0.65%
1/153 • Number of events 2
|
0.00%
0/147
|
|
Infections and infestations
Pneumonia
|
3.3%
5/153 • Number of events 5
|
2.0%
3/147 • Number of events 3
|
|
Infections and infestations
Post procedural infection
|
0.65%
1/153 • Number of events 2
|
0.00%
0/147
|
|
Infections and infestations
Pseudomembranous colitis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Respiratory tract infection
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Infections and infestations
Sepsis
|
0.65%
1/153 • Number of events 1
|
1.4%
2/147 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/153 • Number of events 2
|
2.7%
4/147 • Number of events 4
|
|
Injury, poisoning and procedural complications
Airway complication of anesthesia
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/153 • Number of events 2
|
2.0%
3/147 • Number of events 5
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
6.5%
10/153 • Number of events 14
|
8.8%
13/147 • Number of events 20
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/153
|
1.4%
2/147 • Number of events 2
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.6%
4/153 • Number of events 4
|
2.0%
3/147 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metas
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastics
|
0.65%
1/153 • Number of events 2
|
0.68%
1/147 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal menigioma
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/153
|
1.4%
2/147 • Number of events 2
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.00%
0/153
|
1.4%
2/147 • Number of events 2
|
|
Psychiatric disorders
Bipolar disorder
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Psychiatric disorders
Fear of falling
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Psychiatric disorders
Major depression
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Psychiatric disorders
Pseudodementia
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Psychiatric disorders
Suicide attempt
|
1.3%
2/153 • Number of events 2
|
0.00%
0/147
|
|
Renal and urinary disorders
renal disorder
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/153 • Number of events 3
|
1.4%
2/147 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/153
|
1.4%
2/147 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
2/153 • Number of events 2
|
0.68%
1/147 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
1/153 • Number of events 1
|
0.68%
1/147 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Surgical and medical procedures
Bladder catheter replacement
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Surgical and medical procedures
Drug delivery device implantation
|
0.65%
1/153 • Number of events 1
|
0.00%
0/147
|
|
Surgical and medical procedures
Subdural haematoma evacuation
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/153
|
1.4%
2/147 • Number of events 2
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/153
|
0.68%
1/147 • Number of events 2
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/153
|
0.68%
1/147 • Number of events 1
|
Other adverse events
| Measure |
Kiva VCF Treatment System
n=153 participants at risk
Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
|
Balloon Kyphoplasty
n=147 participants at risk
Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
|
|---|---|---|
|
General disorders
Oedema peripheral
|
2.0%
3/153 • Number of events 3
|
1.4%
2/147 • Number of events 2
|
|
General disorders
Pain
|
0.65%
1/153 • Number of events 1
|
2.0%
3/147 • Number of events 3
|
|
Infections and infestations
Herpes zoster
|
2.0%
3/153 • Number of events 3
|
0.68%
1/147 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.0%
3/153 • Number of events 3
|
0.68%
1/147 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
4/153 • Number of events 4
|
1.4%
2/147 • Number of events 4
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/153
|
2.0%
3/147 • Number of events 3
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
32.0%
49/153 • Number of events 74
|
27.2%
40/147 • Number of events 58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/153 • Number of events 2
|
2.7%
4/147 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.5%
39/153 • Number of events 52
|
27.9%
41/147 • Number of events 45
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/153
|
2.0%
3/147 • Number of events 3
|
|
Nervous system disorders
Reflexes abnormal
|
4.6%
7/153 • Number of events 8
|
2.0%
3/147 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
3/153 • Number of events 3
|
0.00%
0/147
|
Additional Information
Barbara S. Lindsay, Vice President Clinical & Regulatory Affairs
Benvenue Medical, Inc.
Phone: 408-454-9300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place