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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Painful Osteoporotic Vertebral Compression Fractures (VCF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Vertebral Augmentation (STABILIT)

Intervention Type DEVICE

Vertebral Augmentation with the STABILIT Vertebral Augmentation System

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.

Group Type ACTIVE_COMPARATOR

Non-operative Management

Intervention Type OTHER

Conservative Care

Interventions

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Vertebral Augmentation (STABILIT)

Vertebral Augmentation with the STABILIT Vertebral Augmentation System

Intervention Type DEVICE

Non-operative Management

Conservative Care

Intervention Type OTHER

Other Intervention Names

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Kyphoplasty Radiofrequency Targeted Vertebral Augmentation (RF-TVA) Radiofrequency Kyphoplasty (RFK) Medical Management

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No