• Rudolf Bertagnoli, James J Yue, Rahul V Shah, Regina Nanieva, Frank Pfeiffer, Andrea Fenk-Mayer, Trace Kershaw, and Daniel S Husted.
• St. Elizabeth Klinikum, Spine Center, Straubing, Germany.
• Spine. 2005 Oct 1; 30 (19): 2230-6.

Study DesignProspective, longitudinal minimum 2-year follow-up.ObjectiveTo assess the efficacy and safety of the Prodisc implant in patients with disabling single-level discogenic low back pain (LBP).Summary Of Background DataThe treatment of debilitating discogenic LBP has been controversial and varied. To date, a longitudinal prospective study of the treatment of single-level incapacitating discogenic LBP using the Prodisc total disc arthroplasty technique has not been described.MethodsA prospective analysis was performed on 118 patients treated with single-level lumbar Prodisc total disc arthroplasty. Patients 18 to 60 years of age with disabling and recalcitrant discogenic LBP with or without radicular pain secondary to single-level discogenic LBP from L3 to S1 were included. Patients were assessed before surgery, and outcome measurements were after surgery administered at 3, 6, 12, and 24 months.ResultsA total of 104 patients (88%) fulfilled all follow-up criteria. The median age of all patients was 47 years (range, 36-60 years). Statistical improvements in VAS, Oswestry, and patient satisfaction scores occurred 3 months postoperatively. These improvements were maintained at the 24-month follow-up. Radicular pain also decreased significantly. Full-time and part-time work rates increased from 10% to 35% and 3% to 24%, respectively. No additional fusion surgeries were necessary either at the affected or unaffected levels. Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm (P < 0.001) and an affected disc motion from 3 degrees to 7 degrees (P < 0.004).ConclusionsSingle-level Prodisc lumbar total disc arthroplasty is a safe and efficacious treatment method for debilitating lumbar discogenic LBP. Significant improvements in patient satisfaction and disability scores occurred after surgery by 3 months and were maintained at the 2-year follow-up. No device-related complications occurred. Patients with severe to moderate disc height loss as well as those with symptomatic posterior anular defects with minimal disc height loss achieve functional gains and significant pain relief. Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes.

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