Health Services Research

The Treatment of Disabling Multilevel Lumbar Discogenic Low Back Pain With Total Disc Arthroplasty Utilizing the ProDisc Prosthesis

A Prospective Study With 2-Year Minimum Follow-up

Bertagnoli, Rudolf MD*; Yue, James J. MD†; Shah, Rahul V. MD†; Nanieva, Regina BA‡; Pfeiffer, Frank MD‡; Fenk-Mayer, Andrea MD‡; Kershaw, Trace PhD§; Husted, Daniel S. MD†

Author Information

From the *St. Elizabeth Klinikum, Spine Center, Straubing, Germany; †Department of Orthopaedic Surgery and Rehabilitation, Yale University, New Haven, CT; ‡Department of Orthopaedic Surgery, Spine Center, St. Elizabeth Klinikum, Straubing, Germany; and §School of Public Health, Yale University, New Haven, CT.

Acknowledgment date: April 30, 2004. First revision date: August 31, 2004. Second revision date: October 25, 2004. Acceptance date: November 1, 2004.

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.

No funds were received in support of this work. Although one or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other nonprofit organization which the author(s) has/have been associated.

Address correspondence and reprint requests to James J. Yue, MD, Yale University School of Medicine, Department of Orthopaedic Surgery and Rehabilitation, 800 Howard Avenue, P.O. Box 208071, New Haven, CT 06520; E-mail: [email protected]

Spine 30(19):p 2192-2199, October 1, 2005. | DOI: 10.1097/01.brs.0000181061.43194.18

Study Design. 

Prospective, longitudinal minimum 2-year follow-up.

Objective. 

To assess the efficacy and safety of the Prodisc implant in patients with disabling multilevel discogenic low back pain (LBP).

Summary of Background Data. 

Few, if any, alternatives have been proposed to treat recalcitrant and debilitating multilevel lumbar discogenic low back pain. To date, a prospective study specifically examining the use of multilevel Prodisc total disc arthroplasty has not been described

Methods. 

A prospective analysis was performed on 25 patients (63 prostheses) treated with multilevel lumbar ProDisc total disc arthroplasty. Minimum follow-up was 2 years. Patients 18 to 60 years of age with disabling discogenic low back pain and minimal radicular pain secondary to multiple level lumbar spondylosis from L1 to S1 were included. Preoperative and postoperative disability and pain scores were measured using Oswestry and visual analog scores. Preoperative and postoperative neurologic, radiographic, and pain medication assessments were also performed at similar postoperative intervals.

Results. 

A total of 29 patients (72 prostheses) were enrolled in the prospective analysis. Twenty-five patients (63 prostheses) fulfilled all follow-up criteria and are included for final analysis. Fifteen bisegmental and 10 trisegmental level cases were performed. Visual analog pain, Oswestry, and patient satisfaction scores were significantly reduced at the 3-month as well as at 48-month follow-up. Radiographic analysis revealed an affected disc height increases from 5 mm to 12 mm (P < 0.05) and affected disc motions from 3° to 7° (P < 0.05). No change in adjacent level disc heights was seen.

Complications included a single case of subsidence of the inferior endplate of the L4–L5 segment in a bisegmental L4–L5/L5–S1 case. We also report a delayed case of anterior extrusionof a polyethylene component in a patient who had sustained a fall of a bicycle.

Conclusions. 

Our preliminary data on multisegmental ProDisc lumbar total disc arthroplasty appear to be a safe and efficacious treatment method for debilitating lumbar spondylosis without significant facet arthropathy. In our select (non-Workers Compensation and/or medical legal) cohort of patients, we demonstrate a patient satisfaction rate of 93%. Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes.

© 2005 Lippincott Williams & Wilkins, Inc.

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