Five-year results of lumbar disc prostheses in the SWISSspine registry
- 710 Downloads
The Swiss Federal Office of Public Health demanded a nationwide HTA registry for lumbar total disc arthroplasty (TDA), to decide about its reimbursement. The goal of the SWISS spine registry is to generate evidence about the safety and efficiency of lumbar TDA.
Two hundred forty-eight cases treated between 3-2005 and 6-2006, who were eligible for the 5-year follow-up were included in the study. Follow-up rates for 3–6 months, 1, 2 and 5 years were 85.9, 77.0, 44.0 and 51.2 %, respectively. Outcome measures were back and leg pain, medication consumption, quality of life, intraoperative and postoperative complication and revision rates. Additionally, segmental mobility, ossification, adjacent and distant segment degeneration were analysed at the 5-year follow-up.
There was a significant, clinically relevant and lasting reduction of back (preop/postop 73/29 VAS points) and leg pain (preop/postop VAS 55/22) and a consequently decreased analgesics consumption and quality of life improvement (preop/postop 0.30/0.76 EQ-5D score points) until 5 years after surgery. The rates for intraoperative and early postoperative complications were 4.4 and 3.2 %, respectively. The overall complication rate during five postoperative years was 23.4 %, and the adjacent segment degeneration rate was 10.7 %. In 4.4 % of patients, a revision surgery was performed. Cumulative survivorship probability for a revision/re-intervention-free 5-year postoperative course was 90.4 %. At the 5-year follow-up, the average range of motion of the mobile segments (86.8 %) was 9.7°. In 43.9 % of patients, osteophytes at least potentially affecting the range of motion were seen.
Lumbar TDA appeared as efficient in long-term pain alleviation, consequent reduction of pain medication consumption and improvement of quality of life. The procedure also appeared sufficiently safe, but surgeons have to be aware of a list of potential adverse events. The outcome is stable over the 5-year postoperative period. The vast majority of treated segments remained mobile after 5 years, although almost half of patients showed osteophytes.
KeywordsSWISSspine TDA Disc arthroplasty Lumbar disc prosthesis Long-term follow-up
The authors are thankful to the SWISSspine registry group who made this research possible by populating the database with their valuable and much appreciated entries. Among others, data of the following colleagues were used in the study: Etter C (n = 26), Bärlocher C (n = 24), Sgier F (n = 24), Huber J (n = 17), Otten P (n = 15), Heini P (n = 13), Hausmann O (n = 12), Maestretti G (n = 11), Baur M (n = 9), Porchet F (n = 9), Markwalder T (n = 8), Renella R (n = 8), Schaeren S (n = 6), Self T (n = 6), Schwarzenbach O (n = 5), Kast E (n = 4), Kleinstück F (n = 4), Lattig F (n = 4), Min K (n = 4), Schizas C (n = 4), Berlemann U (n = 3), Grob D (n = 3), Hasdemir M (n = 3), Marchesi D (n = 3), Aebi M (n = 2), Binggeli R (n = 2), Boscherini D (n = 2), Favre J (n = 2), Forster T (n = 2), Jeanneret B (n = 2), Moulin P (n = 2), Tessitore E (n = 2), Boos N (n = 1), Cathrein P (n = 1), Kroeber M (n = 1), Payer M (n = 1), Ramadan A (n = 1), Stoll T (n = 1), Wernli F (n = 1). Funded by the AO Foundation start-up-grant S-10-41A.
Conflict of interest
- 2.Zigler JE, Delamarter RB (2012) Five-year results of the prospective, randomized, multicenter, Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the treatment of single-level degenerative disc disease. J Neurosurg Spine 17:493–501PubMedCrossRefGoogle Scholar
- 3.Guyer RD, McAfee PC, Banco RJ, Bitan FD, Cappuccino A, Geisler FH, Hochschuler SH, Holt RT, Jenis LG, Majd ME, Regan JJ, Tromanhauser SG, Wong DC, Blumenthal SL (2009) Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up. Spine J 9:374–386PubMedCrossRefGoogle Scholar
- 5.Aghayev E, Elfering A, Schizas C, Mannion AF, Group SWR (2014) Factor analysis of the North American Spine Society outcome assessment instrument: a study based on a spine registry of patients treated with lumbar and cervical disc arthroplasty. Spine J 14(6):916–924. doi: 10.1016/j.spinee.2013.07.446 PubMedCrossRefGoogle Scholar
- 6.McAfee PC, Cunningham B, Holsapple G, Adams K, Blumenthal S, Guyer RD, Dmietriev A, Maxwell JH, Regan JJ, Isaza J (2005) A prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: part II: evaluation of radiographic outcomes and correlation of surgical technique accuracy with clinical outcomes. Spine (Phila Pa 1976) 30:1576–1583 (discussion E1388–1590)CrossRefGoogle Scholar
- 14.Zweig T, Aghayev E, Melloh M, Dietrich D, Dietrich D, Roder C, SWISSspine Registry Group (2012) Influence of preoperative leg pain and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry. Eur Spine J 21(Suppl 6):S729–S736PubMedCrossRefGoogle Scholar
- 17.IEFM (2014) University of Bern. www.memdoc.org
- 30.McAfee PC, Geisler FH, Saiedy SS, Moore SV, Regan JJ, Guyer RD, Blumenthal SL, Fedder IL, Tortolani PJ, Cunningham B (2006) Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE artificial disc. Spine (Phila Pa 1976) 31:1217–1226CrossRefGoogle Scholar
- 37.Neukamp M, Perler G, Pigott T, Munting E, Aebi M, Roder C (2013) Spine Tango annual report 2012. Eur Spine J. doi: 10.1007/s00586-013-2943-x (in press)
- 39.Breakwell LM (2013) Understanding the need for spinal registries: Lee Breakwell reviews the importance of registries in spinal research and explains why British Association of Spinal Surgeons (BASS) has decided to set up its own registry. Eur Spine J 22(1):S5–S6. doi: 10.1007//s00586-013-2666-z
- 40.Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS (2009) Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. Four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. JBJS Am 91:1295–1304PubMedCrossRefPubMedCentralGoogle Scholar
- 41.Rohlmann A, Lauterborn S, Dreischarf M, Schmidt H, Putzier M, Strube P, Zander T (2013) Parameters influencing the outcome after total disc replacement at the lumbosacral junction. Part 1: misalignment of the vertebrae adjacent to a total disc replacement affects the facet joint and facet capsule forces in a probabilistic finite element analysis. Eur Spine J 22(10):2271–2278PubMedCrossRefGoogle Scholar
- 42.Zweig T, Hemmeler C, Aghayev E, Melloh M, Etter C, Roder C (2011) Influence of preoperative nucleus pulposus status and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry. BMC Musculoskelet Disord 12:275PubMedCrossRefPubMedCentralGoogle Scholar