Painful Osteoporotic Vertebral Compression Fractures (VCF)Phase 4PRIORi-TNCT01480167
The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation
A Phase 4 study testing Vertebral Augmentation (STABILIT) and Non-operative Management in people with Painful Osteoporotic Vertebral Compression Fractures (VCF), run by DFINE Inc. at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Painful Osteoporotic Vertebral Compression Fractures (VCF)
- What is being tested?
- Vertebral Augmentation (STABILIT) and Non-operative Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Penn State Hershey Medical Center, Department of Radiology
Hershey, Pennsylvania, 17033
Dartmouth-Hitchcock Medical Center, Department of Radiology
Lebanon, New Hampshire, 03756
Winthrop University Hospital, Department of Radiology
Mineola, New York, 11501
Swedish Neuroscience Institute, Cherry Hill Campus, Department of Neurosurgery
Seattle, Washington, 98122
Washington University - Mallinckrodt Institute of Radiology
St Louis, Missouri, 63110
Montefiore Hospital/Einstein Medical School, Department of Radiology
The Bronx, New York, 10467
About this study
Official title: Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation (The PRIORi-T Trial)
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).
Read the 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.
- Being tested
- Vertebral Augmentation (STABILIT), Non-operative Management
- Keywords
- VCF, Osteoporosis, Minimally Invasive, Non-operative management, Medical Management
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Augmentation (STABILIT)Device
Also called Kyphoplasty, Radiofrequency Targeted Vertebral Augmentation (RF-TVA), Radiofrequency Kyphoplasty (RFK)
Vertebral Augmentation with the STABILIT Vertebral Augmentation System
Non-operative ManagementOther
Also called Medical Management
Conservative Care
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Non-operative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale.
Measured: 1 month
Secondary outcomes (4)
Change in VAS from baseline at the 3, 6, and 12 month follow-up visits.
Measured: 3, 6, and 12 months
Change in Roland-Morris Questionnaire (RDQ) from baseline at the 1, 3, 6, and 12 month follow-up visits.
Measured: 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.
Measured: 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.
Measured: 1,3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Osteoporotic Vertebral Compression Fractures (VCF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DFINE Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan Brook, M.D., Principal investigator, Montefiore Hospital/Einstein Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480167
- Sponsor's protocol ID
- NCC-10-005 - PRIORI-T
- Acronym
- PRIORi-T
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2011
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Investigation of Radiofrequency Targeted Vertebral Augmentation (The PRIORi-T Trial)
- ClinicalTrials.gov ID
- NCT01480167
- Acronym / sponsor ID
- PRIORi-T / NCC-10-005 - PRIORI-T
- Keywords
- VCF, Osteoporosis, Minimally Invasive, Non-operative management, Medical Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DFINE Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- First posted
- 28 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF-TVA with STABILIT Vertebral Augmentation System | Active comparator | Device: Vertebral Augmentation (STABILIT)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). |
| Non Operative Management | Active comparator | Other: Non-operative ManagementAll 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vertebral Augmentation (STABILIT)Also: Kyphoplasty, Radiofrequency Targeted Vertebral Augmentation (RF-TVA), Radiofrequency Kyphoplasty (RFK)Vertebral Augmentation with the STABILIT Vertebral Augmentation System | Device | RF-TVA with STABILIT Vertebral Augmentation System |
| Non-operative ManagementAlso: Medical ManagementConservative Care | Other | Non Operative Management |
Primary outcome
Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale.
Time frame: 1 month
4 secondary outcomes
Change in VAS from baseline at the 3, 6, and 12 month follow-up visits.
Time frame: 3, 6, and 12 months
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Brook, M.D. principal investigator
Montefiore Hospital/Einstein Medical School
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vertebral Augmentation (STABILIT) and Non-operative Management in people with Painful Osteoporotic Vertebral Compression Fractures (VCF), run by DFINE Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in back pain from baseline at the 1 month follow-up visit as measured by the Visual Analog Scale. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.