Vertebral Body Compression Fractures (VCFs)Phase 4MDTSCORENCT00810043
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
A Phase 4 study testing Kyphon® Curette in people with Vertebral Body Compression Fractures (VCFs), run by Medtronic Spine LLC at 13 sites in 3 countries.
Trial summary
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Vertebral Body Compression Fractures (VCFs)
- What is being tested?
- Kyphon® Curette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Feb 2009to Oct 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 50 years
- One painful VCF meeting all of the following criteria:
- Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis
- VCF is between T5 and L5
- VCF shows hyperintense signal on STIR or T2 weighted MRI
- VCF has at least 15% height loss as visualized on plain radiograph
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- Identified painful VCF has at least superior and one normal vertebrae within 2 levels inferior.
- Either the immediate superior OR the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment.
- Patient states availability for all study visits
- Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
Who cannot join
- Patient is unable to undergo MRI
- Patient shows evidence of edema in vertebral bodies other than index level on MRI
- Patient is unable to stand for pre-operative and post-operative x-rays
- Patient body mass index (BMI) is greater than 35 kg/m2
- Patient is pregnant, or of child-bearing potential and not using contraception
- Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF
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- Index fracture is result of high-energy trauma
- Suspected or proven cancer inside any VB
- Disabling back pain due to causes other than acute fracture
- Spine stabilization beyond balloon kyphoplasty required for index VCF
- Pre-existing conditions contrary to balloon kyphoplasty, such as:
- Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
- Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used.
- Any evidence of VB or systemic infection
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Germany8 sites
Charité Campus Virchow-Klinikum Berlin
Berlin, 13353
Kliniken im Naturpark Altmühltal
Eichstätt, 85072
Klinikum Kempten
Kempten, 87439
Klinikum Leverkusen gGmbH
Leverkusen, 51375
Paracelcus-Klinik München
München, 81679
Kliniken Dr. Erler
Nuremberg, 90429
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, 93049
Asklepios Orthopadische Klinik Lindenlohe
Schwandorf in Bayern, 92421
United States3 sites
Aurora Medical Group, Memorial Hospital of Burlington
Burlington, Wisconsin, 53105
Atrium Medical Center
Middletown, Ohio, 45005
Foundation for Orthopaedic Research and Education
Temple Terrace, Florida, 33637
Belgium2 sites
CHC - Les Cliniques Saint-Joseph
Liège, 4000
St. Augustinus ziekenhuis
Wilrijk, 2610
About this study
Official title: Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
- Being tested
- Kyphon® Curette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphon® CuretteDevice
The Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures
| Study group | Role | What they receive |
|---|---|---|
| Curette-First | Active comparator | All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps. Receives: Device: Kyphon® Curette |
| IBT-First | Active comparator | All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps. Receives: Device: Kyphon® Curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Measured: Baseline and 48-hr post-procedure
Secondary outcomes (7)
Index Vertebral Body Height Restored in Millimeters.
Vertebral Body Height (VBH) was measured at anterior, midpoint, and posterior of index vertebral bodies. The data presented is the absolute height restored (AHR) between two time points.
Measured: Baseline and 48 hours after procedure
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Since all patients were treated in the prone position with chest and hip bolsters (this is referred to as postural reduction), vertebral body height (VBH) gained from IBTs alone was reported as the change of vertebral body height measured intra-operatively after postural reduction with bolsters to the 1st round of IBT inflation.
Measured: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Measured: baseline and intra-operative
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Measured: Baseline and 48 hr post-procedure
Deformity Correction Assessed by Local Cobb Angle (LCA)
The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below. Correction of angular deformity was expressed as a difference of absolute values between pre- and post-operative values. Any positive change indicated an improvement of angular correction and was defined as a change in angulation toward 0 degrees. Any negative change indicated a worsening of angular correction, and is defined as a change away from 0 degrees.
Measured: baseline and 48 hr post-procedure
Change in Back Pain.
Back pain was assessed by a numeric rating scale (Scale 1-10), with higher scores denoting worse pain.
Measured: Baseline and 48 hr post-procedure
Change in Ambulatory Status
Ambulatory status was assessed by subjective patient questionnaire.
Measured: Baseline and 48 hrs post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionOct 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral Body Compression Fractures (VCFs)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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Fueredi, M.D., Principal investigator, Aurora Heath Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810043
- Sponsor's protocol ID
- SP0801 - SCORE
- Acronym
- MDTSCORE
- Status last verified
- Apr 2014
- First submitted
- 12 Dec 2008
- Last updated
- 8 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bastian L, Schils F, Tillman JB, Fueredi G; SCORE Investigators. A randomized trial comparing 2 techniques of balloon kyphoplasty and curette use for obtaining vertebral body height restoration and angular-deformity correction in vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2013 Mar;34(3):666-75. doi: 10.3174/ajnr.A3363. Epub 2012 Nov 22.
PubMed 23179647
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
- ClinicalTrials.gov ID
- NCT00810043
- Acronym / sponsor ID
- MDTSCORE / SP0801 - SCORE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medtronic Spine LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Posted 30 Nov 2011
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 study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curette-First | Active comparator | Device: Kyphon® CuretteAll of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps. |
| IBT-First | Active comparator | Device: Kyphon® CuretteAll of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >= 50 years
- One painful VCF meeting all of the following criteria:
- Patient states availability for all study visits
- Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
Key exclusion criteria (14 listed)
- Patient is unable to undergo MRI
- Patient shows evidence of edema in vertebral bodies other than index level on MRI
- Patient is unable to stand for pre-operative and post-operative x-rays
- Patient body mass index (BMI) is greater than 35 kg/m2
- Patient is pregnant, or of child-bearing potential and not using contraception
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 |
|---|---|---|
| Kyphon® CuretteThe Kyphon® Curette is intended to scrape and score bone in the spine. It may be used as an adjunctive device with Kyphon's family of standard access and fracture reduction instruments designed to treat compression fracture during balloon kyphoplasty procedures | Device | Curette-First, IBT-First |
Primary outcome
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
Time frame: Baseline and 48-hr post-procedure
7 secondary outcomes
Index Vertebral Body Height Restored in Millimeters.
Time frame: Baseline and 48 hours after procedure
Amount of Vertebral Body Height (VBH) Gained From IBTs Alone
Time frame: Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.
Amount of Vertebra Body Height (VBH) Gained by Postural Reduction
Time frame: baseline and intra-operative
Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)
Time frame: Baseline and 48 hr post-procedure
Deformity Correction Assessed by Local Cobb Angle (LCA)
Time frame: baseline and 48 hr post-procedure
Change in Back Pain.
Time frame: Baseline and 48 hr post-procedure
Change in Ambulatory Status
Time frame: Baseline and 48 hrs post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23179647Bastian L, Schils F, Tillman JB, Fueredi G; SCORE Investigators. A randomized trial comparing 2 techniques of balloon kyphoplasty and curette use for obtaining vertebral body height restoration and angular-deformity correction in vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2013 Mar;34(3):666-75. doi: 10.3174/ajnr.A3363. Epub 2012 Nov 22.
Related trials for Vertebral Body Compression Fractures (VCFs)
Active, not recruiting
RISE - Study of the AGN1 LOEP SV Kit in Patients With Vertebral Compression Fractures
Vertebral Compression Fracture, Vertebral Compression
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.
George Fueredi, M.D. principal investigator
Aurora Heath Care, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Kyphon® Curette in people with Vertebral Body Compression Fractures (VCFs), run by Medtronic Spine LLC at 13 sites in 3 countries.
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 10 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: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, United States, Belgium. 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?
Yes. Results are posted in the registry (first posted 30 Nov 2011). 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?
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) (time frame: Baseline and 48-hr post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810043, which also lists 1 linked publication.
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 8 Dec 2017.