FREE Study - Fracture Reduction Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spine LLC
ClinicalTrials.gov Identifier:
NCT00211211
First received: September 13, 2005
Last updated: April 18, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Osteopenia
Osteoporosis
Multiple Myeloma
Bone Neoplasms
Device: Balloon Kyphoplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Medtronic Spine LLC:

Primary Outcome Measures:
  • 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).
  • Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
  • 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:
  • The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
  • procedural safety (peri-operative clinical events)
  • 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
  • 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)
  • changes in spinal deformity as measured radiographically at baseline, 3, 12 and 24 months.
  • 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.
  • patient satisfaction at 1, 3, 6, 12, 24 months
  • outcome (nursing home, back to status prior to fracture) at 1, 3, 6, 12, 24 months
  • economic aspects (including hospital days, disabilities, etc.) at 1, 3, 6, 12, 24 months
  • the cost-effectiveness of kyphoplasty expressed in incremental cost/quality adjusted life year gained at different time points (1 year and 2 years)
  • rate of incident fractures at 3, 12 and 24 months (frequency, timing and location)
  • Each endpoint will be compared between the 2 groups and for its evolution over time.

Estimated Enrollment: 300
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211211

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
Medtronic Spine LLC
Investigators
Principal Investigator: Prof. Johnell, MD UMRA - Malmo, Sweden
  More Information

No publications provided by Medtronic Spine LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Spine LLC
ClinicalTrials.gov Identifier: NCT00211211     History of Changes
Other Study ID Numbers: SP0201 - FREE Study
Study First Received: September 13, 2005
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Spine LLC:
Osteopenia
Osteoporosis
Multiple Myeloma
Osteolytic Metastatic Tumors
Vertebral Compression Fracture
Back Pain
Spine

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Bone Diseases, Metabolic
Osteoporosis
Fractures, Compression
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014