FREE Study - Fracture Reduction Evaluation

NCT00211211 | Completed Phase 4

• 1 other identifier: SP0201 - FREE Study
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia; Osteoporosis; Multiple Myeloma; Bone Neoplasms

Keywords

Osteopenia; Osteoporosis; Multiple Myeloma; Osteolytic Metastatic Tumors; Vertebral Compression Fracture; Back Pain; Spine

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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.

Interventions

Balloon Kyphoplasty DEVICE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medtronic Spine LLC: lead

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (4)

• 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.

  PMID: 23446769 DERIVED

• 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.

  PMID: 22443312 DERIVED

• 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.

  PMID: 21912321 DERIVED

• 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.

  PMID: 19246088 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Multiple Myeloma; Bone Neoplasms; Back Pain

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vertebroplasty; Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Prof. Johnell, MD

  UMRA - Malmo, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 8, 2017

Record last verified: 2012-01

Locations

US (1)