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FREE Study - Fracture Reduction Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00211211
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal and Biologics ( Medtronic Spine LLC )

Study Description
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Brief Summary:
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.

Condition or disease Intervention/treatment Phase
Osteopenia Osteoporosis Multiple Myeloma Bone Neoplasms Device: Balloon Kyphoplasty Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures
Study Start Date : February 2003
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral compression fractures (VCFs).
  2. Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
  3. The primary study endpoint is the change in quality of life as measured by the Physical Component Summary (PCS) scale of the 36-Item Short Form (SF-36) as measured at the one-month follow-up visit.

Secondary Outcome Measures :
  1. The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
  2. procedural safety (peri-operative clinical events)
  3. function as measured by objective functionality tests-reaching, "get up and go" and by the subjective Roland Morris disability questionnaire at 1, 3, 6, 12 and 24 months
  4. pain using a 10-point visual analogue scale (VAS) at 5-10 days (post enrollment for the control group and post kyphoplasty for the kyphoplasty group)
  5. changes in spinal deformity as measured radiographically at baseline, 3, 12 and 24 months.
  6. Maintenance of vertebral body height will be assessed from lateral spine x-rays obtained in Kyphoplasty treated subjects only at baseline and at 3, 12, and 24 month visits.
  7. patient satisfaction at 1, 3, 6, 12, 24 months
  8. outcome (nursing home, back to status prior to fracture) at 1, 3, 6, 12, 24 months
  9. economic aspects (including hospital days, disabilities, etc.) at 1, 3, 6, 12, 24 months
  10. the cost-effectiveness of kyphoplasty expressed in incremental cost/quality adjusted life year gained at different time points (1 year and 2 years)
  11. rate of incident fractures at 3, 12 and 24 months (frequency, timing and location)
  12. Each endpoint will be compared between the 2 groups and for its evolution over time.

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum of one painful, acute (edema present on MRI obtained within a two weeks period prior to enrolment) thoracic or lumbar (T5-L5) vertebral body compression fracture, due to osteopenia arising from primary or secondary osteoporosis, multiple myeloma, or osteolytic metastatic tumors and maximum of three painful fractures requiring treatment. (NOTE: a T2-weighted MRI should be done unless it is not available);
  • 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:

  • Previous vertebroplasty;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211211


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Medtronic Spine LLC
Investigators
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Principal Investigator: Prof. Johnell, MD UMRA - Malmo, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00211211    
Other Study ID Numbers: SP0201 - FREE Study
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: January 2012
Keywords provided by Medtronic Spinal and Biologics ( Medtronic Spine LLC ):
Osteopenia
Osteoporosis
Multiple Myeloma
Osteolytic Metastatic Tumors
 Vertebral Compression Fracture
Back Pain
Spine
Additional relevant MeSH terms:
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Multiple Myeloma
Bone Neoplasms
Osteoporosis
Bone Diseases, Metabolic
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Neoplasms by Site