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

NCT01480167 | Withdrawn Phase 4

• 1 other identifier: NCC-10-005 - PRIORI-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Painful Osteoporotic Vertebral Compression Fractures (VCF)

Keywords

VCF; Osteoporosis; Minimally Invasive; Non-operative management; Medical Management

Outcome Measures

Primary Outcomes (1)

• Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale.

  1 month

Secondary Outcomes (4)

• Change in VAS from baseline at the 3, 6, and 12 month follow-up visits.

  3, 6, and 12 months

• Change in Roland-Morris Questionnaire (RDQ) from baseline at the 1, 3, 6, and 12 month follow-up visits.

  1,3,6,12 months

• Change in SF-36 physical component score from baseline at the 1, 3, 6, and 12 month follow-up visits.

  1,3,6,12 months

• Change in IOF Quality of Life Questionnaire from baseline at the 1, 3, 6, and 12 month follow-up visits.

  1,3,6,12 months

Study Arms (2)

RF-TVA with STABILIT Vertebral Augmentation System

ACTIVE COMPARATOR

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)

Non Operative Management

ACTIVE COMPARATOR

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

Interventions

Vertebral Augmentation (STABILIT) DEVICE

Vertebral Augmentation with the STABILIT Vertebral Augmentation System

Also known as: Kyphoplasty, Radiofrequency Targeted Vertebral Augmentation (RF-TVA), Radiofrequency Kyphoplasty (RFK)

RF-TVA with STABILIT Vertebral Augmentation System

Non-operative Management OTHER

Conservative Care

Also known as: Medical Management

Non Operative Management

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 21 and ≤ 90 years of age.
• 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).
• 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.
• Subject has a history of vertebral fracture-related back pain ≤ 8 weeks old at time of enrollment (confirmed by medical history).
• 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).
• Subject has a Roland Morris Disability Questionnaire (RDQ) score ≥ 10 on scale of 0 to 24 at time of enrollment.
• Subject is a suitable candidate for minimally invasive VCF procedure.
• 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.
• 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.

You may not qualify if:

• Subject's VCF morphology is deemed unsuitable for RF-TVA in the judgment of the Investigator.
• Subject requires additional non-kyphoplasty or vertebroplasty surgical treatment for the index fracture.
• Subject has surgery to the spine planned for at least one (1) month following enrollment.
• Subject has high-energy trauma-related and/or, non-osteoporotic vertebral fractures.
• Subject has a spinal cord compression or significant canal compromise requiring decompression, in the judgment of the investigator.
• 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).
• Subject has irreversible coagulopathy or bleeding disorder.
• 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).
• Subject has significant clinical co-morbidities that may potentially interfere with the collection of data concerning pain and function.
• Subject has a known allergy to device materials (e.g. polymethylmethacrylate (PMMA) or barium).
• Subject has a contraindication to local or general anesthesia.
• Subject has a medical and/or surgical condition contrary to the kyphoplasty or vertebroplasty procedure (e.g. presence of local or systemic infection).
• Subject is receiving Worker's Compensation.
• Subject is a prisoner.

Sponsors & Collaborators

• DFINE Inc.: lead

Study Sites (6)

Washington University - Mallinckrodt Institute of Radiology

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center, Department of Radiology

Lebanon, New Hampshire, 03756, United States

Location

Winthrop University Hospital, Department of Radiology

Mineola, New York, 11501, United States

Location

Montefiore Hospital/Einstein Medical School, Department of Radiology

The Bronx, New York, 10467, United States

Location

Penn State Hershey Medical Center, Department of Radiology

Hershey, Pennsylvania, 17033, United States

Location

Swedish Neuroscience Institute, Cherry Hill Campus, Department of Neurosurgery

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Kyphoplasty; Practice Management, Medical

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Allan Brook, M.D.

  Montefiore Hospital/Einstein Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

US (6)