title: The treatment of disabling single-level 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 single-level discogenic low back pain (LBP).
  
  
  BACKGROUND
  The 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.
  
  
  METHODS
  A 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.
  
  
  RESULTS
  A 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).
  
  
  CONCLUSIONS
  Single-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.
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; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery*; D017116:Low Back Pain / Q000209:etiology / Q000503:physiopathology* / Q000523:psychology; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010166:Palliative Care; D017060:Patient Satisfaction; D011446:Prospective Studies; D011859:Radiography; D013122:Spinal Diseases / Q000150:complications* / Q000000981:diagnostic imaging / Q000601:surgery*; D016896:Treatment Outcome