STUDY DESIGN: Prospective multicenter observational case-series. OBJECTIVE: The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of these Medtech innovations. SUMMARY OF BACKGROUND DATA: The Swiss federal office of public health required a mandatory nationwide HTA-registry for cervical total disc arthroplasty (TDA), among other technologies, to decide about reimbursement of these interventions. METHODS: Between March 2005 and June 2008, 808 interventions with implantation of 925 discs from 5 different suppliers were performed. Surgeon-administered outcome instruments were primary intervention, implant, and follow-up forms; patient self-reported measures were EQ-5D, COSS, and a comorbidity questionnaire. Data are recorded perioperative, at 3 months and 1 year postoperative, and annually thereafter. RESULTS. There was significant and clinically relevant reduction of neck (preoperative/postoperative 59.3/24.8 points) and arm pain (preoperative/postoperative 64.9/17.6) on visual analogue scale (VAS) and consequently decreased analgesics consumption. Similarly, quality of life (QoL) improved from preoperative 0.42 to postoperative 0.82 points on EQ-5D scale. There were 4 intraoperative complications and 23 revisions during the same hospitalization for 691 monosegmental TDAs, and 2 complications and 6 revisions for 117 2-level surgeries. A pharmacologically treated depression was identified as important risk factor for achieving a clinically relevant pain alleviation >20 points on VAS. Two-level surgery resulted in similar outcomes compared with the monosegmental interventions. CONCLUSION: Cervical TDA appeared as safe and efficacious in short-term pain alleviation, consequent reduction of pain killer consumption, and in improvement of QoL. A clinically relevant pain reduction of >/=20 points was most probable if patients had preoperative pain levels >/=40 points on VAS. A pharmacologically treated depression and 2-level surgery were identified as risk factors for less pronounced pain alleviation or QoL improvement
Keywords : Adult,adverse effects,Aged,Analgesics,Arm,Arthroplasty,Arthroplasty,Replacement,Cervical Vertebrae,Chi-Square Distribution,Comorbidity,complications,etiology,Evidence-Based Medicine,Female,Government Regulation,Health Care Surveys,Hospitalization,Humans,instrumentation,Intervertebral Disc Degeneration,Intraoperative Complications,Logistic Models,Male,methods,Middle Aged,Neck,Pain,Pain Measurement,Patients,prevention & control,Prospective Studies,Prosthesis Design,Quality of Life,Registries,Reoperation,Risk Assessment,Risk Factors,Safety,surgery,Surveys and Questionnaires,Switzerland,therapeutic use,Time Factors,Treatment Outcome,Young Adult,, Governmentally, repetitive strain injury in hand
Date of Publication : 2010 Nov 15
Authors : Schluessmann E;Aghayev E;Staub L;Moulin P;Zweig T;Roder C;
Organisation : Institute for Evaluative Research in Orthopedic Surgery, University of Bern, Bern, Switzerland
Journal of Publication : Spine (Phila Pa 1976 )
Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/21030901
The London Spine Unit : Harley Street UK. Specialists in Cutting Edge Technologies for Spinal Surgery
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