Clinical Trial
Journal Article
Multicenter Study
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Bioabsorbable anterior cervical plating: initial multicenter clinical and radiographic experience.

Spine 2007 May 2
STUDY DESIGN: Prospective clinical trial.

OBJECTIVE: The authors present their initial multicenter experience in the surgical management of 1-level degenerative disc disease of the cervical spine with anterior cervical discectomy and fusions (ACDF) using a bioabsorbable polymer plate.

SUMMARY OF BACKGROUND DATA: The introduction of a radiolucent bioabsorbable polymer plate and screws for ACDF presents a novel opportunity to gain the some of the potential added benefit of stabilization with internal immobilization while possibly reducing some of the long-term complications and imaging artifacts associated with titanium instrumentation. We prospectively analyze 52 patients who were treated at 6 different institutions across the United States with bioabsorbable polymer plate and screws for ACDF surgery.

METHODS: Patients were prospectively enrolled. A retrospective review of patients' charts and imaging was performed to determine clinical and radiographic outcome following anterior cervical spine surgery. Specifically, the authors looked at need for additional surgeries, local reaction to bioabsorbable polymer, fusion rate, and complications. Surgeries involved the C4-C5, C5-C6, C6-C7, and/or C7-T1 levels. Cadaveric bone was used in 42 patients, polyetheretherketone (PEEK) cages in 6 patients, and iliac crest autograft in 4 patients. The patients were observed for an average of 13.3 months.

RESULTS: Radiographic fusion was achieved in 98.1% (51 of 52 patients) of the cases at 6 months. One patient has evidence of nonunion on flexion-extension imaging but remains asymptomatic. A different patient developed mild kyphosis after surgery and had persistence of radicular symptoms but refused further surgery. There were no clinical signs or symptoms of reaction to the bioabsorbable material.

CONCLUSIONS: The rates of fusion following single-level ACDF with internal fixation using bioabsorbable polymer plate and screws in this study match those previously reported in the literature with metallic implants and are superior to noninstrumented fusions. Preliminary results suggest that this newly available technology for anterior fusion may be as effective as traditional titanium plating systems in single-level disease. The bioabsorbable material appears to be well tolerated by patients. A larger, randomized, controlled study is necessary to bring the results to statistical significance.

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