Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures

IRB Number: 26033

inactive

July 17, 2006

Institutional Review Board, Hospital for Special Surgery

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Principal Investigator

Joseph M. Lane, MD

Co-Investigators

Folorunsho Edobor-Osula
Lisa Shindle, NP
Mike Gardner, MD
Michael Shindle, MD
Stephen Lyman, PhD

Summary

This is a randomized prospective clinical trial to compare the effectiveness of unipedicular vs. bipedicular balloon kyphoplasty for the treatment of vertebral body compression fractures. We intend to enroll 140 subjects from Hospital for Special Surgery with a follow-up of 24-months. The primary endpoint of the study will be mean improvement in functional status, as measured by the Oswestry Disability Index from baseline to the 1-month follow-up visit.

Inclusion/Exclusion Criteria

Inclusion Criteria

Adults between the ages of 40 and 99+ who have had osteoporosis associated vertebral compression fractures that warrant surgical management via kyphoplasty.
Pain NRS score >= 4 on a scale of 0 to 10
No major surgery to the spine planned for at least 1 month following enrollment
Life expectancy of >= 3 months
Patient has sufficient mental capacity to comply with the protocol requirements
Patient has stated availability for all study visits
Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent

Exclusion Criteria

Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
Significant clinical morbidities (aside from the index fracture (s) and cancer) that may potentially interfere with the collection of data concerning pain and function
VCF morphology deemed unsuitable for balloon kyphoplasty
Additional non-kyphoplasty surgical treatment is required for the index fracture
Patients requiring the use of high-dose steroid (>= 100mg prednisone or 20 mg dexamethasone per day), IV pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
Patients with platelet count of <20,000 measured at the time of hospital admission for the procedure
Spinal cord compression or canal compromise requiring decompression
Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors of vertebral levels intended for kyphoplasty may be enrolled.
Medical/surgical conditions contrary to the balloon kyphoplasty procedure (e.g., in the presence of active or incompletely treated local infection)
Known allergy to bone cement or contrast medium used in the treatment of study subjects
MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
Positive baseline pregnancy test (for women of child-bearing potential)
Patients who may require allogeneic bone marrow transplantation during the course of the study

Contact Information

Metabolic Bone Disease Research Office
Attn: Dr. Joseph Lane
535 East 70th st.
New York, NY 10021
(212) 606-1344