The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation

This study has suspended participant recruitment.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
DFINE Inc.
ClinicalTrials.gov Identifier:
NCT01480167
First received: November 23, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

The objective of this post market clinical investigation is to evaluate the clinical effectiveness of a minimally invasive vertebral augmentation procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA) as compared to non-operative management (NOM) for the treatment of appropriately diagnosed acute (≤ 8 weeks) painful osteoporotic vertebral compression fractures (VCF).


Condition Intervention Phase
Painful Osteoporotic Vertebral Compression Fractures (VCF)
Device: Vertebral Augmentation (STABILIT)
Other: Non-operative Management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation (The PRIORi-T Trial)

Resource links provided by NLM:


Further study details as provided by DFINE Inc.:

Primary Outcome Measures:
  • Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in VAS from baseline at the 3, 6, and 12 month follow-up visits. [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Change in Roland-Morris Questionnaire (RDQ) from baseline at the 1, 3, 6, and 12 month follow-up visits. [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: No ]
  • Change in SF-36 physical component score from baseline at the 1, 3, 6, and 12 month follow-up visits. [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: No ]
  • Change in IOF Quality of Life Questionnaire from baseline at the 1, 3, 6, and 12 month follow-up visits. [ Time Frame: 1,3,6,12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: November 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RF-TVA with STABILIT Vertebral Augmentation System
All RadioFrequency-Targeted Vertebral Augmentation (RF-TVA) arm participants will be treated with the StabiliT Vertebral Augmentation System. This system is a commercially available device in the United States designed to perform percutaneous vertebral augmentation (also known as kyphoplasty).
Device: Vertebral Augmentation (STABILIT)
Vertebral Augmentation with the STABILIT Vertebral Augmentation System
Other Names:
  • Kyphoplasty
  • Radiofrequency Targeted Vertebral Augmentation (RF-TVA)
  • Radiofrequency Kyphoplasty (RFK)
Active Comparator: Non Operative Management
All non-operative management (NOM) arm participants will receive non-operative standard of care management, which can include: analgesics, bed rest, back braces, physiotherapy, rehabilitation programs, and walking aids according to standard practices of participating institutions.
Other: Non-operative Management
Conservative Care
Other Name: Medical Management

Detailed Description:

This is a multi-center, prospective, randomized, post marketing clinical trial designed to evaluate the clinical effectiveness of a minimally invasive procedure, Radiofrequency-Targeted Vertebral Augmentation (RF-TVA), compared to Non Operative Management (NOM) for the treatment of appropriately diagnosed, acute (≤ 8 weeks), painful, osteoporotic vertebral compression fractures. Eligible subjects will be randomly allocated to receive either RF-TVA or NOM in a 1:1 randomization ratio. Subjects will be followed for 12 months post procedure. Primary effectiveness will be determined by comparing the Visual Analogue Scale for each treatment group for back pain from the baseline to the 1-month post procedure visit and between treatment groups at 1-month.

Up to 15 sites will participate in this trial.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is ≥ 21 and ≤ 90 years of age.
  2. Subject has one (1) to three (3) painful vertebral compression fracture(s) at T5-L5 due to primary or secondary osteoporosis (i.e. non-malignant) and recent history of sudden onset of pain in area of index vertebra (e).
  3. Subject's index vertebra (e) is confirmed as the active source of back pain as evidenced by concordant pain and bone marrow edema via magnetic resonance imaging (MRI) or Computerized Tomography (CT) plus bone scan.
  4. Subject has a history of vertebral fracture-related back pain ≤ 8 weeks old at time of enrollment (confirmed by medical history).
  5. Subject has a pain related VAS score ≥ 5 on a scale of 0 to 10 at time of enrollment. Pain represents the worst level of back pain while standing, walking or elevating from chair, bed, or car during the preceding 24 hours associated with the index vertebra (e).
  6. Subject has a Roland Morris Disability Questionnaire (RDQ) score ≥ 10 on scale of 0 to 24 at time of enrollment.
  7. Subject is a suitable candidate for minimally invasive VCF procedure.
  8. Subject has sufficient mental and physical capacity to comply with the Investigational Plan requirements and is willing and able to provide informed consent; agrees to release medical information for the purposes of this study; and agrees to comply with the Investigational Plan requirements and return for specified follow-up evaluations.
  9. Subject is a male; a documented infertile female (either postmenopausal or surgical contraception); or is a non-pregnant, non-lactating female of childbearing potential who agrees to use a medically accepted method of birth control throughout the duration of the trial.

Exclusion Criteria:

  1. Subject's VCF morphology is deemed unsuitable for RF-TVA in the judgment of the Investigator.
  2. Subject requires additional non-kyphoplasty or vertebroplasty surgical treatment for the index fracture.
  3. Subject has surgery to the spine planned for at least one (1) month following enrollment.
  4. Subject has high-energy trauma-related and/or, non-osteoporotic vertebral fractures.
  5. Subject has a spinal cord compression or significant canal compromise requiring decompression, in the judgment of the investigator.
  6. Subject has a neurologic deficit associated with the vertebral level(s) to be treated that is more severe than radiculopathy (e.g. myelopathy, cauda equina syndrome).
  7. Subject has irreversible coagulopathy or bleeding disorder.
  8. Subject requires, at time of enrollment, the use of high-dose steroids (e.g. ≥ 100 mg prednisone or 20 mg dexamethasone per day), intravenous (IV) pain medication, or nerve block to control chronic back pain unrelated to index VCF(s).
  9. Subject has significant clinical co-morbidities that may potentially interfere with the collection of data concerning pain and function.
  10. Subject has a known allergy to device materials (e.g. polymethylmethacrylate (PMMA) or barium).
  11. Subject has a contraindication to local or general anesthesia.
  12. Subject has a medical and/or surgical condition contrary to the kyphoplasty or vertebroplasty procedure (e.g. presence of local or systemic infection).
  13. Subject is receiving Worker's Compensation.
  14. Subject is a prisoner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480167

Locations
United States, Missouri
Washington University - Mallinckrodt Institute of Radiology
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Department of Radiology
Lebanon, New Hampshire, United States, 03756
United States, New York
Montefiore Hospital/Einstein Medical School, Department of Radiology
Bronx, New York, United States, 10467
Winthrop University Hospital, Department of Radiology
Mineola, New York, United States, 11501
United States, Pennsylvania
Penn State Hershey Medical Center, Department of Radiology
Hershey, Pennsylvania, United States, 17033
United States, Washington
Swedish Neuroscience Institute, Cherry Hill Campus, Department of Neurosurgery
Seattle, Washington, United States, 98122
Sponsors and Collaborators
DFINE Inc.
Investigators
Principal Investigator: Allan Brook, M.D. Montefiore Hospital/Einstein Medical School
  More Information

No publications provided

Responsible Party: DFINE Inc.
ClinicalTrials.gov Identifier: NCT01480167     History of Changes
Other Study ID Numbers: NCC-10-005 - PRIORI-T
Study First Received: November 23, 2011
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DFINE Inc.:
VCF
Osteoporosis
Minimally Invasive
Non-operative management
Medical Management

Additional relevant MeSH terms:
Fractures, Compression
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014