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

Study Overview
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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).

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.

Official Title
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Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation (The PRIORi-T Trial)

Conditions
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Painful Osteoporotic Vertebral Compression Fractures (VCF)

Intervention / Treatment
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* Device: Vertebral Augmentation (STABILIT)
* Other: Non-operative Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RF-TVA with STABILIT Vertebral Augmentation System<br>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)<br>* Vertebral Augmentation with the STABILIT Vertebral Augmentation System<br>* Other names: Radiofrequency Kyphoplasty (RFK);|
| Active Comparator: Non Operative Management<br>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<br>* Conservative Care<br>* Other names: Medical Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VCF, Osteoporosis, Minimally Invasive, Non-operative management, Medical Management