Biomet Spine & Bone Healing Technologies

Published Clinical Data

A Controlled Prospective Outcome Study of Implantable Electrical Stimulation With Spinal Instrumentation in a High-Risk Spinal Fusion Population
Spine; Volume 24(5). 1 March 1999, p. 465-468;
Kucharzyk, Donald W., DO

"The results of the current study indicate that when surgical correction via instrumentation and fusion is planned, electrical stimulation should be considered. The combination of instrumentation and implantable electrical stimulation addresses the best of three worlds: correctability of deformity, an increased chance for successful arthrodesis of the spine, and a statistically significant cost saving for the insurance carrier and patient, with improved overall outcomes."

50% Increase in Fusion Success Rates over Autograft Alone in an Uninstrumented Model(1)

  • Randomized Prospective Controlled Trail(1)
  • An "ethical substitution" for a human double blind study (did not want to implant inactive units in patients)
  • Produced precisely matched cohorts of patients
  • Radiographic fusion assessed by blinded independent radiologists achieved in 25 of 31 DC-treated patients (81%), but only 15 of 28 control patients "in situ" (54%) (See figure above)

Difficult to Fuse Patient Studies

11-13% Increase in Fusion Success Rates with an SpF® Stimulator compared to without an SpF® Stimulator in difficult to fuse patients in an Instrumented Model(2, 3)

  • Instrumented compared to instrumented with an SpF® Stimulator in difficult to fuse patients
  • Overall 96% of stimulated patients fused compared to 85% of unstimulated patients. (See figure above)(2)
  • In a separate study, instrumented alone had a 87% fusion success rate; whereas instrumented with SpF® direct current technology had a 96% fusion success rate(3)

High-risk patients with previous surgeries, multi-level fusions, and those who smoked post-operatively had improved fusion success rates when treated with an SpF Stimulator (see Figures below)(2).

Difficult to Fuse Patient Studies

To learn more about published clinical data, please refer to the SpF® Stimulator Technical Monograph found below.

SpF® Stimulator Technical Monograph.pdf
* P850035
These charts were created by Biomet based on published data.
  • Kane, W.J. Direct current electrical bone growth stimulation for spinal fusion. Spine (Phila Pa 1976), 1988.13(3): p. 363-5.
  • Rogozinski, A. and Rogozinski, C. Efficacy of implanted bone growth stimulation in instrumented lumbosacral spinal fusion. Spine (Phila Pa 1976), 1996. 21(21): p. 2479-83.
  • Kucharzyk, D.W. A controlled prospective outcome study of implantable electrical stimulation with spinal instrumentation in a high-risk spinal fusion population. Spine (Phila Pa 1976), 1999. 24(5): p. 465-8;discussion 469.8 Morone, M.A. et al. Gene Expression During Autograft Lumbar Spine Fusion and the Effect of Bone Morphogenetic Protein 2. CORR. 1998;351: 252-265

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