General Session: Tumor, Trauma, and Infection
Presented by: M.R. Chambers - View Audio/Video Presentation (Members Only)
M.R. Chambers(1), D.P. Beall(2), D.K. Datta(3), R.W. Easton(4), B.S. Goodman(5), D.A. Linville ll(6), S. Talati(7), S. Thomas(8), J. Webb(9)
(1) University of Alabama at Birmingham, Neurological Surgery, Birmingham, AL, United States
(2) Clinical Radiology of Oklahoma, Radiology, Edmond, OK, United States
(3) Spine Specialty Center, Orthopedic Surgery, Melbourne, FL, United States
(4) Oakland University - William Beaumont School of Medicine, Surgery, Troy, MI, United States
(5) Alabama Orthopedic, Spine & Sports Medicine Associates, Physiatry, Birmingham, AL, United States
(6) Spine Specialty Center, Orthopedic Surgery, Memphis, TN, United States
(7) Central Michigan University, Associate Professor, Mount Pleasant, MI, United States
(8) Allegheny College, Meadville, PA, United States
(9) Musculoskeletal Imaging of Tulsa, Interventional Radiology, Tulsa, OK, United States
Background: Vertebral compression fractures (VCF) resulting from osteoporosis or cancer are common and painful. Worldwide, osteoporosis causes more than 8.9 million fractures annually. Quality of life is threatened and mortality and morbidity rates increase following a VCF. Kyphoplasty is a minimally invasive procedure to restore vertebral body height when possible, stabilize the fracture, reduce pain, and improve quality of life and mobility. Methodology: Following institutional review board (IRB) approval, 354 Medicare eligible subjects with painful, acute or subacute VCF were prospectively enrolled at 24 sites in the United States with 350 undergoing kyphoplasty. The study protocol identified four co-primary endpoints at 3 months. These included the short form 36 question physical component summary (SF-36v2 PCS) and Euroqol-5-domain (EQ-5D) quality of life assessments, the numeric rating scale (NRS) for back pain and the Oswestry disability index (ODI). The primary objective was to assess for statistically significant improvement in four co-primary endpoints at 3 months. Data was collected at baseline and at 1, 3, 6 and 12 months; NRS was also collected 7 days post-operatively.
Results: The SF-36 PCS average baseline score of 24.2 points (scale 0 to 100) improved to 36.6 and EQ-5D had an average baseline score of 0.383 (scale 0 to 1), which improved to 0.746 at the 3 month time point (p< 0.001 for each). Similarly, back pain with an average baseline NRS score of 8.7 (scale 0 to 10) improved to 2.7 and ODI with an average baseline score of 63.4 (scale 0 to 100) improved to 27.1 at the 3-month time point (p< 0.001 for each). The four co-primary endpoints showed significant improvement at each interval throughout the study and each measure improved further at 12 months. With statistically significant improvement from baseline in the four co-primary endpoints at 3 months, the primary objective of the study was met. There were five reported device-related or procedure-related adverse events (AE). These included one of each of the following: asymptomatic balloon rupture, transient rib pain, aspiration pneumonia, a new VCF 25 days post-procedure, and myocardial infarction 105 days post-procedure. Symptoms associated with these AE resolved with appropriate treatment. Asymptomatic cement leakage was reported in 107/499 (21.4%) index levels treated.
Conclusion: This large, prospective, multicenter trial demonstrates that kyphoplasty is a safe, very effective and durable procedure for treating Medicare patients with VCF due to osteoporosis or cancer.