Pathologic Fracture of the Vertebra Due to OsteoporosisNCT00933036
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
A study testing Crosstrees Pod system for PVA in people with Pathologic Fracture of the Vertebra Due to Osteoporosis, run by Crosstrees Medical Inc. at 9 sites in United States.
Trial summary
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pathologic Fracture of the Vertebra Due to Osteoporosis
- What is being tested?
- Crosstrees Pod system for PVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2009to Jun 2013
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 50 years old.
- Patient must have a fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in the study).
- Patient must have confirmed acute pain and tenderness over the spine at or near the level of x-ray compression deformity OR positive MRI evaluation.
- Patient must NOT have more than (3) three vertebral compression fractures located between T4 and L5.
- Subjects affected vertebral body must have a loss of 0- 50% in vertebral height as compared with the height of an adjacent normal vertebral body confirmed by radiological evaluation.
- Subject fracture is confirmed by MRI imaging including T1, T2 and STIR-weighted studies to determine the type and presence of fracture(s).
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- Subjects affected vertebral body height and geometry is adequate for insertion of access instruments of 5.2mm OD, as determined by the investigator.
- Subjects pain score is equal to or greater than 5 according to the visual analog scale (VAS).
- Patient has been evaluated for hematologic disorders or other conditions affecting blood coagulation.
- Subjects are suitable candidates for standard vertebroplasty or kyphoplasty procedures.
- Subject is psychosocially, mentally, and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plans, completing forms, and other study procedures.
- Subject signed the Informed Consent Form prior to any study related procedures indicating that he/she has been informed of all pertinent aspects of the trial.
- Failure of conservative treatment prior to inclusion: a. failed conservative treatment arm; b. acute therapy treatment arm.
Who cannot join
- Patient has significant vertebral collapse, defined as > 50% of the original height of the vertebral body, as measured against the nearest normal vertebral body. Degree of collapse will be determined by using the height of the nearest normal vertebral body to represent 100% and dividing the height of the collapsed vertebral body by the height of the normal vertebral body.
- Patient has compromised spinal canal.
- Patient has symptomatic spinal stenosis.
- Patient has painful VCF with fracture age greater than 6 months.
- Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
- Patient has a fracture that extends into the posterior vertebral body wall.
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- Patient has neurological compromise (including myelopathy) and instability
- Patient has a retropulsion severe enough to cause myelopathy, unless prior surgical decompression is performed.
- Patient with significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
- Patient requires the use of high-dose steroid, IV pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
- Patient who may require allogenic bone marrow transplantation during the course of the study.
- Patient is in need of an open decompression.
- Patient with burst fracture, and/or pedicle fracture at the treatment level.
- Patient with a known or suspected allergy to PMMA or allergy to any device material used in the treatment of vertebral fractures. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used.
- Patient does not have local pain and tenderness that correlates with MRI evaluation.
- Patient has a coagulation disorder that cannot be corrected: a. for patients with hematologic disorders or other conditions affecting blood coagulation, a platelet count and internationalized normal ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT) values should be available at time intervals typical of the treatment center. The Investigator is to evaluate the ranges relative to the normal values of the treatment center laboratory.
- Patient has an active local or systemic infection.
- Patient has a previous or current treatment for cancer at the affected level.
- Patient has a previous spine surgery or previous injection of cement at the vertebral levels of the surgical procedure.
- Patient has diabetes mellitus.
- Patient has an MRI contraindication (e.g., cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
- Patient has an unstable spine as indicated by neurologic deficit, kyphosis greater than 30°, compression greater than 60%, translation greater than 4 mm, interspinous-process widening.
- Pre-existing conditions contrary to either PVA or vertebroplasty, such as: a. Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants; b. Any evidence of VB or systemic infection.
- Patient has a mental deficiency (e.g., psychiatric disorders, Alzheimer's disease, presence of alcohol or drug abuse).
- Patient is pregnant or is interested in becoming pregnant during the study duration.
- Patient is a prisoner or ward of the state.
- Patient expects to relocate more than 50 miles from the study center prior to completion of the study follow-up period.
- Patient has an AO classification A2, A3, B or C type fracture
- Patient has hemangioma, malignant fracture, and/or multiple myeloma at the site of the index VCF.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
St. Alexius Medical Center
Bismarck, North Dakota, 58506
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
The Spine Institute - Rocky Mountain Orthopedic
Cheyenne, Wyoming, 82001
Advanced Imaging & Interventional Institute
Clearwater, Florida, 33761
Orthopedic Clinic of Daytona Beach
Daytona Beach, Florida, 32117
Broward Spine Institute
Hollywood, Florida, 33021
Long Beach Memorial Medical Center
Long Beach, California, 90806
Physician's Regional Healthcare System
Naples, Florida, 34119
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Clinical Evaluation of the Crosstrees® System for PVA in Symptomatic Adult Patients With Acute Vertebral Body Compression Fractures at T4-L5
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Read the detailed description
Every year in the United States more than 700,000 people suffer from compression fractures of the spinal column , and the number of people affected is much higher across the world. Osteoporosis is the main cause of fractures of the vertebral bodies. Other causes of vertebral fractures include malignant processes including benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma), infections and trauma; however, osteoporosis is by far the main cause of this problem.
In a normal person, the vertebral bodies are composed of a porous structure called trabecular or spongy bone encapsulated within a thin external cap of cortical (dense) bone. In a person with osteoporosis, the trabeculae that form the central porous bone become thinner and weaker. When this occurs, the vertebral bodies begin to fracture and become deformed. This deformation of the vertebral bodies is classified into three types, according to the shape: wedge, biconcave, and crush. The degree of severity of these deformations is classified as grade A1.1, grade A1.2, or grade A1.3
The Crosstrees PVA™ Pod™ is a device designed to percutaneously provide controlled delivery of PMMA bone filler material during vertebral augmentation. The Crosstrees PVA System for Percutaneous Vertebral Augmentation (PVA) is designed for use with Crosstrees Fortibrae PMMA. The system is novel in providing the ability to control the delivery of PMMA to the vertebral body without the need for an additional permanent implant to remain within the patient. The Crosstrees System for Percutaneous Vertebral Augmentation will be used with Crosstrees Access Tools, which are regulated as Class I exempt orthopedic manual surgical instruments.
- Being tested
- Crosstrees Pod system for PVA
- Keywords
- Osteoporosis, VCF, PVA, Vertebroplasty, Kyphoplasty, Vertebral fracture, Pathologic fracture, Vertebral augmentation
- Medical subject headings
- Osteoporosis, Spinal Fractures, Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crosstrees Pod system for PVADevice
Also called Vertebroplasty, Kyphoplasty, PVA, Vertebral Augmentation
Minimally invasive spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Crosstrees Pod System for PVA. Receives: Device: Crosstrees Pod system for PVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant.
Measured: Six months
Secondary outcomes (4)
Ambulatory Status/Physical Function
Measured: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Quality of life
Measured: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Neurological Assessment
Measured: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Vertebral Body Morphology
Measured: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic Fracture of the Vertebra Due to OsteoporosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crosstrees Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank M Phillips, MD, Study chair, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933036
- Sponsor's protocol ID
- G080175
- Status last verified
- Jan 2014
- First submitted
- 5 Jul 2009
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Crosstrees® System for PVA in Symptomatic Adult Patients With Acute Vertebral Body Compression Fractures at T4-L5
- ClinicalTrials.gov ID
- NCT00933036
- Acronym / sponsor ID
- G080175
- Keywords
- Osteoporosis, VCF, PVA, Vertebroplasty, Kyphoplasty, Vertebral fracture, Pathologic fracture, Vertebral augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Crosstrees Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jul 2009 (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 clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Detailed description
Every year in the United States more than 700,000 people suffer from compression fractures of the spinal column , and the number of people affected is much higher across the world. Osteoporosis is the main cause of fractures of the vertebral bodies. Other causes of vertebral fractures include malignant processes including benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma), infections and trauma; however, osteoporosis is by far the main cause of this problem.
In a normal person, the vertebral bodies are composed of a porous structure called trabecular or spongy bone encapsulated within a thin external cap of cortical (dense) bone. In a person with osteoporosis, the trabeculae that form the central porous bone become thinner and weaker. When this occurs, the vertebral bodies begin to fracture and become deformed. This deformation of the vertebral bodies is classified into three types, according to the shape: wedge, biconcave, and crush. The degree of severity of these deformations is classified as grade A1.1, grade A1.2, or grade A1.3
The Crosstrees PVA™ Pod™ is a device designed to percutaneously provide controlled delivery of PMMA bone filler material during vertebral augmentation. The Crosstrees PVA System for Percutaneous Vertebral Augmentation (PVA) is designed for use with Crosstrees Fortibrae PMMA. The system is novel in providing the ability to control the delivery of PMMA to the vertebral body without the need for an additional permanent implant to remain within the patient. The Crosstrees System for Percutaneous Vertebral Augmentation will be used with Crosstrees Access Tools, which are regulated as Class I exempt orthopedic manual surgical instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Crosstrees Pod system for PVACrosstrees Pod System for PVA. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient is at least 50 years old.
- Patient must have a fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in the study).
- Patient must have confirmed acute pain and tenderness over the spine at or near the level of x-ray compression deformity OR positive MRI evaluation.
- Patient must NOT have more than (3) three vertebral compression fractures located between T4 and L5.
- Subjects affected vertebral body must have a loss of 0- 50% in vertebral height as compared with the height of an adjacent normal vertebral body confirmed by radiological evaluation.
Key exclusion criteria (29 listed)
- Patient has significant vertebral collapse, defined as > 50% of the original height of the vertebral body, as measured against the nearest normal vertebral body. Degree of collapse will be determined by using the height of the nearest normal vertebral body to represent 100% and dividing the height of the collapsed vertebral body by the height of the normal vertebral body.
- Patient has compromised spinal canal.
- Patient has symptomatic spinal stenosis.
- Patient has painful VCF with fracture age greater than 6 months.
- Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
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 |
|---|---|---|
| Crosstrees Pod system for PVAAlso: Vertebroplasty, Kyphoplasty, PVA, Vertebral AugmentationMinimally invasive spine surgery | Device | Treatment arm |
Primary outcome
Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant.
Time frame: Six months
4 secondary outcomes
Ambulatory Status/Physical Function
Time frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Quality of life
Time frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Neurological Assessment
Time frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Vertebral Body Morphology
Time frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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.
Frank M Phillips, MD study chair
Rush University Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crosstrees Pod system for PVA in people with Pathologic Fracture of the Vertebra Due to Osteoporosis, run by Crosstrees Medical Inc. at 9 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 13 inclusion and 29 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: finished, as of the sponsor's last update on 23 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant. (time frame: Six months). 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 23 Jan 2014.