IRB Number: 26033
Institutional Review Board, Hospital for Special Surgery
July 17, 2006
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Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Joseph M. Lane, MD
Lisa Shindle NP
Mike Gardner MD
Michael Shindle MD
Stephen Lyman PhD
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.
- 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
- 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
Metabolic Bone Disease Research Office
Attn: Dr. Joseph Lane
535 East 70th st.
New York, NY 10021