Lumbar total disc replacement by less invasive lateral approach: a report of results from two centers in the US IDE clinical trial of the XL TDR® device

European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Antoine G Tohmeh, William D Smith

Abstract

To evaluate the clinical and radiographic outcomes following total disc arthroplasty using the XL TDR(®) Lumbar Disc in the treatment of patients with symptomatic degenerative disc disease at one level between L1-2 and L4-5. Data were compiled from two centers participating in a prospective, multi-center Food and Drug Administration-approved investigational device exemption clinical trial enrolling patients with single-level lumbar degenerative disc disease unresponsive to non-operative treatment. Longitudinal outcomes were evaluated through 3-year follow-up and included patient-reported pain, function, and general health, as well as radiographic measures such as maintenance of disc height and range of motion. The two-center cohort included 64 treated patients, 42 % female, averaging 45.3 years of age (range 26-67). The majority of procedures were performed at the L4-5 level (75 %), uncomplicated, with minimal blood loss (88 % 0-50 cc), and in an outpatient setting (93.8 %). Postoperative events included 10 patients (15.6 %) with new hip flexion weakness, 7 (10.9 %) with new lower extremity weakness, and 10 (15.6 %) with new lower extremity sensory deficits, all resolved by 3 months in all but two patients whose deficits were p...Continue Reading

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Citations

Sep 28, 2016·European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society·Mark MoldavskyBrandon S Bucklen
Oct 22, 2016·Journal of Clinical Neuroscience : Official Journal of the Neurosurgical Society of Australasia·Enrico TessitoreOliver Pascal Gautschi
Dec 27, 2018·Journal of Orthopaedic Surgery and Research·Xu-Dong CuiHui-Lin Yang
Nov 15, 2019·Neurosurgery·Faheem A SandhuRolando Garica
Jul 8, 2017·Journal of Orthopaedics and Traumatology : Official Journal of the Italian Society of Orthopaedics and Traumatology·Matteo FormicaLamberto Felli
Feb 10, 2021·Zhurnal voprosy neĭrokhirurgii imeni N. N. Burdenko·N A KonovalovE S Brinyuk

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