Phase 4
N=120
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
Vertebral Body Compression Fractures (VCFs)
Bottom Line
View on ClinicalTrials.gov: NCT00810043 ↗Enrolled (actual)
120
Serious AEs
11.6%
Results posted
Nov 2011
Primary outcome: Primary: Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) — 9.72; 11.77; 8.14; 9.07 percent change — p=0.430
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Kyphon® Curette (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medtronic Spine LLC
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline) |
9.72; 11.77; 8.14; 9.07; 2.59; 4.21 | 0.430 |
| SECONDARY Index Vertebral Body Height Restored in Millimeters. |
14.15; 14.27; 16.65; 17.32; 2.28; 2.78 | 0.402 |
| SECONDARY Amount of Vertebral Body Height (VBH) Gained From IBTs Alone |
17.03; 18.40; 1.25; 15.99; 17.00; 0.94 | — |
| SECONDARY Amount of Vertebra Body Height (VBH) Gained by Postural Reduction |
14.15; 14.27; 16.93; 17.03; 2.96; 3.05 | 0.900 |
| SECONDARY Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA) |
-15.5; -15.1; -12.4; -11.5; 2.88; 3.00 | 0.889 |
| SECONDARY Deformity Correction Assessed by Local Cobb Angle (LCA) |
-13.8; -11.5; -10.70; -7.88; 1.36; 1.87 | 0.486 |
| SECONDARY Change in Back Pain. |
7.7; 7.5; 3.0; 3.3; -4.7; -4.2 | 0.144 |
| SECONDARY Change in Ambulatory Status |
36; 34; 18; 21; 3; 0 | 0.360 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00810043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.