Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't
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The efficacy of the synthetic interbody cage and Grafton for anterior cervical fusion.

Spine 2009 August 2
STUDY DESIGN: Prospective study of 31 patients who underwent anterior cervical fusion.

OBJECTIVE: To investigate the efficacy of polyetheretherketone (PEEK) cages and demineralized bone matrix (DBM) for anterior cervical discectomy and fusion (ACDF).

SUMMARY OF BACKGROUND DATA: Although high fusion rates can be achieved with autogenous bone grafts, donor-site morbidity affects the patient's satisfaction with the surgical outcome.

METHODS: Thirty-one consecutive patients treated with ACDF using the PEEK cage with DBM (Grafton, Osteotech, Inc., Shrewsbury, NJ) at 42 levels were prospectively evaluated with a minimum of 12-month follow-up (mean: 16 months). Twenty-one patients underwent a single-level ACDF, 9 patients underwent a 2-level ACDF, and 1 patient had a 3-level ACDF. The affected level was C3-C4 in 7 patients; C4-C5 in 9, C5-C6 in 16, and C6-C7 in 10. The neurologic outcomes were evaluated using the VAS score for neck and arm pain and the Japanese Orthopedic Association scoring system for myelopathy at 3, 6, and 12 months. The cervical lordosis and fusion status were assessed on radiographs including flexion/extension radiographs.

RESULTS: At 12 months, the radiographs demonstrated grades I, II, and III new bone formation at 1, 13, and 28 levels, respectively. There was a significant improvement in both the neck and arm pain and a significant improvement in the Japanese Orthopedic Association scores at the last follow-up. There was no case with implant-related complications such as cage failure or migration, and no complications associated with the use of Grafton.

CONCLUSION: ACDF using the Solis cage packed with Grafton demonstrated good clinical and radiologic outcomes. The fusion rate was comparable with the published results of the traditional ACDF using tricortical iliac crest grafts. Therefore, the results of this study suggest that the ongoing use of the PEEK cage packed with DBM and autologous bone chips in ACDF is a safe and effective alternative to the gold standard of autologous iliac bone grafts.

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