title: 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.
abstract: METHODS
  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).
  
  
  BACKGROUND
  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 degrees to 7 degrees (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 extrusion of 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.
authors.affiliation: St. Elizabeth Klinikum, Spine Center, Straubing, Germany.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Bertagnoli
authors.forename: James J
authors.initials: JJ
authors.lastname: Yue
authors.forename: Rahul V
authors.initials: RV
authors.lastname: Shah
authors.forename: Regina
authors.initials: R
authors.lastname: Nanieva
authors.forename: Frank
authors.initials: F
authors.lastname: Pfeiffer
authors.forename: Andrea
authors.initials: A
authors.lastname: Fenk-Mayer
authors.forename: Trace
authors.initials: T
authors.lastname: Kershaw
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Husted
mesh_terms: D000328:Adult; D001178:Arthroplasty / Q000009:adverse effects; D019643:Arthroplasty, Replacement; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006406:Hematoma / Q000209:etiology; D006801:Humans; D007403:Intervertebral Disc / Q000000981:diagnostic imaging / Q000601:surgery*; D017116:Low Back Pain / Q000150:complications / Q000209:etiology* / Q000503:physiopathology* / Q000523:psychology; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000503:physiopathology; D010166:Palliative Care; D017060:Patient Satisfaction; D011446:Prospective Studies; D011843:Radiculopathy / Q000209:etiology / Q000503:physiopathology; D011859:Radiography; D012187:Retroperitoneal Space; D013122:Spinal Diseases / Q000150:complications* / Q000000981:diagnostic imaging / Q000601:surgery*; D040521:Subcutaneous Tissue; D016896:Treatment Outcome; D014938:Work Capacity Evaluation