Håvard Furunes1,2,3, Christian Hellum4, Jens Ivar Brox5,6, Ivar Rossvoll7,8, Ansgar Espeland9,10, Linda Berg11,12, Helga Maria Brøgger13, Milada Cvancarova Småstuen14,15, Kjersti Storheim5,14. 1. Department of Surgery, Innlandet Hospital Gjøvik, Kyrre Grepps Gate 11, 2819, Gjøvik, Norway. havardfurunes@gmail.com. 2. University of Oslo, Blindern, Postbox 1072, 0316, Oslo, Norway. havardfurunes@gmail.com. 3. Oslo University Hospital Ullevål, FORMI, Building 37B, Nydalen, Postbox 4950, 0424, Oslo, Norway. havardfurunes@gmail.com. 4. Division of Orthopaedic Surgery, Oslo University Hospital, Nydalen, Postbox 4950, 0424, Oslo, Norway. 5. University of Oslo, Blindern, Postbox 1072, 0316, Oslo, Norway. 6. Department for Physical Medicine and Rehabilitation, Oslo University Hospital, Nydalen, Postbox 4950, 0424, Oslo, Norway. 7. Department of Orthopaedic Surgery, St Olav's University Hospital, Prinsesse Kristinas Gate 3, 7030, Trondheim, Norway. 8. Department of Neuromedicine, Faculty of Medicine, Norwegian University of Science and Technology, Høgskoleringen 1, 7491, Trondheim, Norway. 9. Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021, Bergen, Norway. 10. Department of Clinical Medicine, University of Bergen, PB 7804, 5020, Bergen, Norway. 11. Department of Radiology, Nordland Hospital, Postbox 1480, 8092, Bodø, Norway. 12. Institute of Clinical Medicine, UiT, The Arctic University of Norway, Langnes, Postbox 6050, 9037, Tromsø, Norway. 13. Department of Radiology and Nuclear Medicine, Oslo University Hospital, Nydalen, Postbox 4950, 0424, Oslo, Norway. 14. Oslo University Hospital Ullevål, FORMI, Building 37B, Nydalen, Postbox 4950, 0424, Oslo, Norway. 15. Department of Health Science, Oslo and Akershus University College of Applied Sciences, St. Olavs Plass, PO Box 4, 0130, Oslo, Norway.
Abstract
PURPOSE: We aimed to identify patient characteristics associated with favourable long-term outcomes after lumbar total disc replacement (TDR). METHODS: We analysed a cohort of 82 patients with degenerative disc and chronic low back pain (LBP) who were treated withTDR and originally participated in a randomised trial comparing TDR and multidisciplinary rehabilitation. Potential predictors were measured at baseline, and the outcomes assessed 8 years after they received allocated treatment. Outcome measures were dichotomised according to whether the participants achieved a clinically important functional improvement (15 points or more on the Oswestry Disability Index, ODI) (primary outcome) and whether they were employed at 8-year follow-up (secondary outcome). Associations between potential predictors and outcomes were modelled using logistic regression. For the secondary outcome, the results were also organised in a prediction matrix and expressed as probabilities. RESULTS: For 71 patients treated with TDR according to protocol, the follow-up time was 8 years. For a subgroup of 11 patients randomised to rehabilitation who crossed over and received TDR, the median postoperative follow-up time was 72 (range 41-88) months. Of all assessed baseline variables, only presence of Modic changes (type 1 and/or 2) was statistically significantly associated with an improvement of ≥ 15 ODI points. The probability of employment at 8-year follow-up was 1% for patients with ≥ 1 year of sick leave, comorbidity, ODI ≥ 50 and ≤ 9 years of education prior to treatment, and 87% for patients with < 1 year of sick leave, no comorbidity, ODI < 50 and higher education. CONCLUSIONS:Patients with Modic changes prior to the TDR surgery were more likely to report a clinically important functional improvement at long-term follow-up. Comorbidity, low level of education, long-term sick leave and high ODI score at baseline were associated with unemployment at long-term follow-up.
RCT Entities:
PURPOSE: We aimed to identify patient characteristics associated with favourable long-term outcomes after lumbar total disc replacement (TDR). METHODS: We analysed a cohort of 82 patients with degenerative disc and chronic low back pain (LBP) who were treated with TDR and originally participated in a randomised trial comparing TDR and multidisciplinary rehabilitation. Potential predictors were measured at baseline, and the outcomes assessed 8 years after they received allocated treatment. Outcome measures were dichotomised according to whether the participants achieved a clinically important functional improvement (15 points or more on the Oswestry Disability Index, ODI) (primary outcome) and whether they were employed at 8-year follow-up (secondary outcome). Associations between potential predictors and outcomes were modelled using logistic regression. For the secondary outcome, the results were also organised in a prediction matrix and expressed as probabilities. RESULTS: For 71 patients treated with TDR according to protocol, the follow-up time was 8 years. For a subgroup of 11 patients randomised to rehabilitation who crossed over and received TDR, the median postoperative follow-up time was 72 (range 41-88) months. Of all assessed baseline variables, only presence of Modic changes (type 1 and/or 2) was statistically significantly associated with an improvement of ≥ 15 ODI points. The probability of employment at 8-year follow-up was 1% for patients with ≥ 1 year of sick leave, comorbidity, ODI ≥ 50 and ≤ 9 years of education prior to treatment, and 87% for patients with < 1 year of sick leave, no comorbidity, ODI < 50 and higher education. CONCLUSIONS:Patients with Modic changes prior to the TDR surgery were more likely to report a clinically important functional improvement at long-term follow-up. Comorbidity, low level of education, long-term sick leave and high ODI score at baseline were associated with unemployment at long-term follow-up.
Entities:
Keywords:
Degenerative disc; Low back pain; Lumbar total disc replacement; Patient selection
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