Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2003-02-28
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Interventions
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Balloon Kyphoplasty
Eligibility Criteria
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Inclusion Criteria
* Minimum of one acute fracture to be treated that has height loss \> 15% of predicted height (average height of two adjacent "normal" vertebrae) when measured at the middle of the vertebral endplate. (NOTE: If the adjacent vertebrae are not normal, the predicted height will be based on the height listed for the fractured vertebra in the table taken from Black et al.)
* Pre-treatment VAS score \> 4 on a scale of 10 where 0 is no pain, 5 is moderate pain and 10 is pain "as bad as you can imagine";
* Patient 21 years of age or older;
* The investigator and surgeon/radiologist agree before randomization that the fracture(s) can technically be reduced using an inflatable bone tamp (IBT); and
* A signed Informed Consent is obtained from the patient.
Exclusion Criteria
* Vertebral body fracture morphology prevents use of devices (such as endplate below pedicles);
* Pedicle fractures;
* Acute fracture(s) to be treated symptomatic \> 3 months at enrollment;
* Pre-existing (not the result of the index fracture) neurological deficit or radicular pain that is not well defined or unstable;
* Spinal cord compression or canal compromise requiring decompression;
* Disabling back pain secondary to causes other than acute fracture;
* Vertebral fracture due to primary or osteoblastic tumors;
* Patient is currently on anticoagulation therapy that can not be interrupted;
* Pre-existing conditions contrary to the kyphoplasty procedure:
* Systemic infection
* Local fractured vertebral body infection
* Temporarily non-reversible bleeding disorder
* Known allergy to any of the drugs, bone void filler material or contrast medium used in the treatment of study subjects
* Dementia and/or inability to give informed consent;
* Inability to walk or stand prior to the vertebral body fracture (walking aids are allowed);
* MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis);
* Pregnancy
* Participation in any other clinical trial within the last 30 days.
21 Years
ALL
No
Sponsors
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Medtronic Spine LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Johnell, MD
Role: PRINCIPAL_INVESTIGATOR
UMRA - Malmo, Sweden
Locations
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University of Alabama
Birmingham, Alabama, United States
Countries
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References
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Van Meirhaeghe J, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D; FREE investigators. A randomized trial of balloon kyphoplasty and nonsurgical management for treating acute vertebral compression fractures: vertebral body kyphosis correction and surgical parameters. Spine (Phila Pa 1976). 2013 May 20;38(12):971-83. doi: 10.1097/BRS.0b013e31828e8e22.
Ranstam J, Turkiewicz A, Boonen S, Van Meirhaeghe J, Bastian L, Wardlaw D. Alternative analyses for handling incomplete follow-up in the intention-to-treat analysis: the randomized controlled trial of balloon kyphoplasty versus non-surgical care for vertebral compression fracture (FREE). BMC Med Res Methodol. 2012 Mar 24;12:35. doi: 10.1186/1471-2288-12-35.
Fritzell P, Ohlin A, Borgstrom F. Cost-effectiveness of balloon kyphoplasty versus standard medical treatment in patients with osteoporotic vertebral compression fracture: a Swedish multicenter randomized controlled trial with 2-year follow-up. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2243-51. doi: 10.1097/BRS.0b013e3182322d0f.
Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24. doi: 10.1016/S0140-6736(09)60010-6. Epub 2009 Feb 24.
Other Identifiers
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SP0201 - FREE Study
Identifier Type: -
Identifier Source: org_study_id