Vertebral Compression FracturesOsseoFixNCT00961714
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
A study testing OsseoFix Spinal Fracture Reduction System in people with Vertebral Compression Fractures, run by Alphatec Spine, Inc. at 11 sites in United States.
Trial summary
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement. Read more about this study
- Who is it for?
- Ages 50 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertebral Compression Fractures
- What is being tested?
- OsseoFix Spinal Fracture Reduction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 5o years of age.
- Legal US citizen with ability to read and write.
- Acute painful fracture (≤2 months) between T6 to L5 as evidenced by plain radiography, CT / Bone scan, and/or magnetic resonance imaging.
- Subject is...
- Non-Standard Treatment:
- Inability to tolerate prolonged conservative care due to intractable pain (VAS 70/100) with maximum tolerated medication for at least 2 weeks, but less than 6 weeks; OR
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- Inability to tolerate prolonged immobilization due to other comorbid conditions aggravated by immobility for at least 2 weeks, but less than 6 weeks; OR
- Intolerance of or adverse reaction to available pain medications for at least 2 weeks, but less than 6 weeks; OR
- Hospitalization secondary to pain for at least 2 weeks, but less than 6 weeks.
- Standard Treatment:
- Has undergone at least 6 weeks of conservative care.
- Have a self assessment VAS score ≥ 50 mm at the Baseline visit.
- Have 30% or greater disability score on ODI at the Baseline visit.
- Anterior wedge deformity with no less than 5% and no more than 75% loss of anterior cortical height as compared to the posterior cortical height of the same vertebral body.
- Bone mineral density (BMD) T-score of -1.5 or less, as determined by a DEXA scan.
- Intact posterior cortical vertebral body wall.
- Type A compression fractures according to AO classification of spinal vertebral fractures.
- If a transpedicular approach is utilized the pedicle diameter must be equal to or greater than 6.5 mm; however, if an extrapedicular approach is utilized there is not a minimum pedicle width requirement.
- Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study (HIPAA authorization) and to return for scheduled follow-up evaluations.
Who cannot join
- Significant vertebral collapse defined as more than 75% of original vertebral height or less than 5% or a burst or pedicle fracture with posterior cortical wall disruption.
- Presence of healed fracture at the intended treatment level(s) based on a CT / bone scan or MRI.
- Compression fractures requiring treatment at 3 or more levels.
- Spinal/Foraminal canal compromised.
- Significant deformity/instability indicated by:
- Segmental kyphosis > 30 degrees, or
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- translation > 4 mm.
- VAS back pain score of < 50 mm.
- ODI score of < 30%.
- Have a documented active systemic or local infection, such as AIDS, hepatitis, with a WBC greater than 11.5 and a temperature greater than 101.5°F.
- Spinal surgery in the thoracic and/or lumbar region within the past year
- Previous kyphoplasty or vertebroplasty at involved level or level above or below treated level.
- Spinal arthrodesis within 2 adjacent levels of fracture.
- Non-ambulatory prior to fracture.
- Greater than Grade 1 spondylolisthesis at level of fracture.
- Scoliosis > 10 degrees.
- BMI > 40.
- Severe cardiopulmonary deficiencies.
- Pregnant.
- Type I or II diabetes without controlled A1C level.
- Achondrogenesis disorders.
- Active malignancy, hemangiomas at the operative level(s), or multiple myeloma.
- No generally accepted medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy with a threshold for INR at 1.5 or less, and platelet count 100,000.
- A life expectancy less than the study duration or undergoing palliative care.
- Trauma injuries aside from vertebral compression fracture(s).
- Injuries that violate the posterior vertebral cortex and/or posterior column.
- Active litigation.
- Currently on workman's compensation.
- Autoimmune disorders.
- Non-spine pain that requires daily Opioids.
- Systemic long-term steroid use - greater than 6 months.
- Active multiple sclerosis or neurologic deficit caudal to fracture.
- Currently an alcohol, solvent, or drug abuser.
- Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements.
- History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)
- Incarcerated.
- Are currently participating in another investigational study.
- Having had another device implanted in the thoracic and/or lumbar area that would interfere with the surgical approach, study device, or follow-up evaluations.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Boulder Neurosurgery Associates
Boulder, Colorado, 80304
Neurospine Solutions, PC
Bristol, Tennessee, 37620
Orthopaedic Associates of the Greater Lehigh Valley Easton Hospital
Easton, Pennsylvania, 18045
Clinical Radiology of Oklahoma
Edmond, Oklahoma, 73034
NeuroSpine Institute, LLC
Eugene, Oregon, 97401
Lyerly Neurosurgery
Jacksonville, Florida, 32207
Scripps
La Jolla, California, 92037
South Denver Neurosurgery
Littleton, Colorado, 80122
Jewish Hospital for Advanced Medicine
Louisville, Kentucky, 40202
Southwestern Orthopedic Center
Savannah, Georgia, 31405
SIU Phyysicians and Surgeons Division of Orthopaedics and Rehabilitation
Springfield, Illinois, 62702
About this study
Official title: Evaluation of Safety and Effectiveness of the OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.
The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US.
This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.
Read the detailed description
This is a prospective, multi-center clinical study designed to evaluate safety and effectiveness of the OsseoFix Spinal Fracture Reduction System used with PMMA bone cement relative to the clinical expectations for treatment of vertebral compression fractures (VCFs). The study will be conducted at up to 15 investigational centers in the United States in 115 (up to 125) subjects with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device(s).
Baseline screening will be completed to determine eligible subjects. VCFs will be confirmed by magnetic resonance imaging (MRI), or by a CT / bone scan. These diagnostic tests will be utilized to confirm that there are no retropulsed bone fragments. Subjects who meet all inclusion criteria and do not have any exclusion criteria will be scheduled to receive the OsseoFix Spinal Fracture Reduction System.
Subjects that are enrolled will be implanted with the OsseoFix Spinal Fracture Reduction System through a postero-lateral approach to the anterior vertebral body using instruments specifically designed for this procedure.
Radiographs will be taken at each follow-up visit, including baseline and post-operatively. Subject's perception of pain will be assessed using the Visual Analogue Scale (VAS). Functional outcomes will be measured using the Oswestry Disability Index (ODI) and Short Form- 36 (SF-36) questionnaires as well as their neurologic status. The VAS, ODI, SF-36 and neurologic status will be measured at baseline, 4-week, 3-month, 6-month and 12-month follow-up visits. Overall patient-satisfaction will be evaluated at all post-implant scheduled follow-up visits. Adverse event will be the recorded in all scheduled and non-scheduled visits.
The endpoint analysis will be performed and submitted when all implanted subjects have completed their 12-months follow-up.
- Conditions
- Vertebral Compression Fractures
- Being tested
- OsseoFix Spinal Fracture Reduction System
- Keywords
- VCF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoFix Spinal Fracture Reduction SystemDevice
All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| OsseoFix | Experimental | Osseofix is an titanium expandable device similar to a vascular stent that is placed in the fractured vertebral body to provide a structure in which bone cement (polymethylmethacrylate) is inserted. It is intended to be used in the thoracolumbar spine between levels T6 through L5. Receives: Device: OsseoFix Spinal Fracture Reduction System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Back Pain Improvement at 12 Months
Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline
Measured: 12 months
Percentage of Participants With Functional Disability Improvement at 12 Months
Functional disability improvement is defined as a reduction in ODI score by ≥ 15 points at 12 months from baseline.
Measured: 12 months
Absence of Device Related Subsequent Interventions or Re-treatment at the Study Treated Levels
Measured: 12 months
Secondary outcomes (3)
Change in Pain at 12 Months as Presented by VAS, When Compared to Baseline
Pain measurements determined by Visual Analog Scale (VAS) on a 100mm scale with, 0=no pain at all, to 100=worse possible pain.
Measured: 12 months
Functional Disability Change at 12months From Baseline as Determined by ODI
Improvement in functional disability as determined by ODI on a scale of 0-50, with 0=no disability at all to 50=complete disability
Measured: 12 months
Any Cement Extravasation Before Discharge
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2012
- Study completionJul 2013
Why it stopped: Withdrew study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vertebral Compression FracturesStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alphatec Spine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Yue, MD, Principal investigator, Yale UniversityDaniel Bennett, MD, Principal investigator, Integrative Treatment Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961714
- Sponsor's protocol ID
- 08-02-A
- Acronym
- OsseoFix
- Status last verified
- Apr 2022
- First submitted
- 17 Aug 2009
- Last updated
- 28 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of the OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
- ClinicalTrials.gov ID
- NCT00961714
- Acronym / sponsor ID
- OsseoFix / 08-02-A
- Conditions
- Vertebral Compression Fractures
- Keywords
- VCF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrew study
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alphatec Spine, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Posted 4 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.
The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US.
This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.
Detailed description
This is a prospective, multi-center clinical study designed to evaluate safety and effectiveness of the OsseoFix Spinal Fracture Reduction System used with PMMA bone cement relative to the clinical expectations for treatment of vertebral compression fractures (VCFs). The study will be conducted at up to 15 investigational centers in the United States in 115 (up to 125) subjects with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device(s).
Baseline screening will be completed to determine eligible subjects. VCFs will be confirmed by magnetic resonance imaging (MRI), or by a CT / bone scan. These diagnostic tests will be utilized to confirm that there are no retropulsed bone fragments. Subjects who meet all inclusion criteria and do not have any exclusion criteria will be scheduled to receive the OsseoFix Spinal Fracture Reduction System.
Subjects that are enrolled will be implanted with the OsseoFix Spinal Fracture Reduction System through a postero-lateral approach to the anterior vertebral body using instruments specifically designed for this procedure.
Radiographs will be taken at each follow-up visit, including baseline and post-operatively. Subject's perception of pain will be assessed using the Visual Analogue Scale (VAS). Functional outcomes will be measured using the Oswestry Disability Index (ODI) and Short Form- 36 (SF-36) questionnaires as well as their neurologic status. The VAS, ODI, SF-36 and neurologic status will be measured at baseline, 4-week, 3-month, 6-month and 12-month follow-up visits. Overall patient-satisfaction will be evaluated at all post-implant scheduled follow-up visits. Adverse event will be the recorded in all scheduled and non-scheduled visits.
The endpoint analysis will be performed and submitted when all implanted subjects have completed their 12-months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OsseoFix | Experimental | Device: OsseoFix Spinal Fracture Reduction SystemOsseofix is an titanium expandable device similar to a vascular stent that is placed in the fractured vertebral body to provide a structure in which bone cement (polymethylmethacrylate) is inserted. It is intended to be used in the thoracolumbar spine between levels T6 through L5. |
Who may qualify
- Ages
- 50 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 5o years of age.
- Legal US citizen with ability to read and write.
- Acute painful fracture (≤2 months) between T6 to L5 as evidenced by plain radiography, CT / Bone scan, and/or magnetic resonance imaging.
- Subject is...
- Have a self assessment VAS score ≥ 50 mm at the Baseline visit.
Key exclusion criteria (38 listed)
- Significant vertebral collapse defined as more than 75% of original vertebral height or less than 5% or a burst or pedicle fracture with posterior cortical wall disruption.
- Presence of healed fracture at the intended treatment level(s) based on a CT / bone scan or MRI.
- Compression fractures requiring treatment at 3 or more levels.
- Spinal/Foraminal canal compromised.
- Significant deformity/instability indicated by:
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 |
|---|---|---|
| OsseoFix Spinal Fracture Reduction SystemAll enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria. | Device | OsseoFix |
Primary outcome
Percentage of Participants With Back Pain Improvement at 12 Months
Time frame: 12 months
Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline
Percentage of Participants With Functional Disability Improvement at 12 Months
Time frame: 12 months
Functional disability improvement is defined as a reduction in ODI score by ≥ 15 points at 12 months from baseline.
Absence of Device Related Subsequent Interventions or Re-treatment at the Study Treated Levels
Time frame: 12 months
3 secondary outcomes
Change in Pain at 12 Months as Presented by VAS, When Compared to Baseline
Time frame: 12 months
Functional Disability Change at 12months From Baseline as Determined by ODI
Time frame: 12 months
Any Cement Extravasation Before Discharge
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
James Yue, MD principal investigator
Yale University
Daniel Bennett, MD principal investigator
Integrative Treatment Centers
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoFix Spinal Fracture Reduction System in people with Vertebral Compression Fractures, run by Alphatec Spine, Inc. at 11 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 19 inclusion and 38 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: stopped early, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Back Pain Improvement at 12 Months (time frame: 12 months). The study lists 3 primary outcomes in all. 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 28 Apr 2022.