Prospective multicenter observational case-series.
The goal of the SWISSspine registry is to generate evidence about the safety and efficiency of these Medtech innovations.
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.
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.
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.
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.
According to the results of 808 interventions with implantation of 925 discs in the SWISSspine registry, cervical total disc arthroplasty appears as safe and efficacious in short-term pain alleviation, consequent reduction of analgesics consumption, and in improvement of quality of life.
From the *Institute for Evaluative Research in Orthopedic Surgery, University of Bern, Bern, Switzerland; †Swiss Paraplegic Center, Nottwil, Switzerland; and ‡Spine Service Inselspital Bern, University Hospital, University of Bern, Bern, Switzerland.
Acknowledgment date: June 24, 2009. Revision date: January 6, 2010. Acceptance date: February 18, 2010.
The manuscript submitted does not contain information about medical device(s)/drug(s).
No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Emin Aghayev, MD, Institute for Evaluative Research in Orthopedic Surgery, University of Bern, Stauffacherstrasse 78, 3014 CH-Bern, Switzerland; E-mail: email@example.com