FREE Study - Fracture Reduction Evaluation

• ClinicalTrials.gov Identifier: NCT00211211
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: December 8, 2017
• Sponsor: Medtronic Spine LLC
• Information provided by (Responsible Party): Medtronic Spinal and Biologics ( Medtronic Spine LLC )

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 21, 2005
• Last Update Posted Date: December 8, 2017
• Study Start Date: February 2003
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2006)

• 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.

Original Primary Outcome Measures (submitted: September 13, 2005)

• 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 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 SF-36 as measured at the one-month follow-up visit.

Current Secondary Outcome Measures (submitted: March 23, 2006)

• 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.

Original Secondary Outcome Measures (submitted: September 13, 2005)

• The secondary study endpoints are:
• • 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 VAS at 5-10 days (post enrollment for the control group and post kyphoplasty for the kyphoplasty group) ; 1, 3, 6, 12 and 24 months
• • 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: FREE Study - Fracture Reduction Evaluation
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Osteopenia
• Osteoporosis
• Multiple Myeloma
• Bone Neoplasms

• Intervention: Device: Balloon Kyphoplasty
• Study Arms: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 13, 2005): 300
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00211211
• Other Study ID Numbers: SP0201 - FREE Study
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Spinal and Biologics ( Medtronic Spine LLC )
• Original Responsible Party: Not Provided
• Current Study Sponsor: Medtronic Spine LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Prof. Johnell, MD; UMRA - Malmo, Sweden

• PRS Account: Medtronic Spinal and Biologics
• Verification Date: January 2012