[The interspinous U implant (now Coflex): long-term outcome, study overview and differential indication].
The safety and effectiveness of the Coflex implant has been confirmed in a large retrospective data analysis. Further studies investigated the long-term clinical outcome up to 12 years and evaluated all associated complications showing a strong safety record. Prospective studies oversee only a small patient population at this point and exhibit scientific shortcomings. A large prospective, randomized, concurrently controlled multicenter trial is underway collecting data in seven spine centers in Germany. A similar study is being performed in the USA with a different control group regulated by the Food and Drug Administration (FDA). A differential indication is the stabilization of an adjacent segment next (above) to a fusion. Stabilization of a functional spinal unit after nucleotomy is not promoted by the author.
Adelt
D
D
Abteilung Neurochirurgie, Ostseeklinik Damp, Seute-Deern-Ring 20, 24351, Damp, Deutschland. dieter.adelt@damp.de
D019299:Decompression, Surgical / Q000295:instrumentation / Q000379:methods*; D019544:Equipment Failure Analysis; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000209:etiology* / Q000601:surgery*; D007595:Joint Prosthesis; D008137:Longitudinal Studies; D011474:Prosthesis Design; D013130:Spinal Stenosis / Q000175:diagnosis / Q000209:etiology* / Q000601:surgery*; D016896:Treatment Outcome
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