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

• Published in: European spine journal 2015-04, Vol.24 (Suppl 3), p.331-338
• Main Authors: Tohmeh, Antoine G., Smith, William D.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Female; Follow-Up Studies; Humans; Intervertebral Disc Degeneration - surgery; Lumbar Vertebrae - surgery; Male; Medicine; Medicine & Public Health; Middle Aged; Neurosurgery; Original Article; Ossification, Heterotopic - epidemiology; Patient Satisfaction - statistics & numerical data; Postoperative Complications; Prospective Studies; Range of Motion, Articular; Surgical Orthopedics; Total Disc Replacement - instrumentation; Total Disc Replacement - methods; United States - epidemiology
• ISSN: 0940-6719; 1432-0932
• DOI: 10.1007/s00586-015-3843-z

Purpose 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. Methods 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. Results 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 prolonged but eventually resolved. Average disc height increased postoperatively from 7.2 to 12.1 mm (69 %), and was 10.7 mm (49 % increase from preoperative) at 3 years. Flexion/extension range of motion averaged 5.9° (SD 4.8°) at 3 years, and was not statistically different from preoperative ( p  = 0.471). Heterotopic ossification interfering with segmental motion was noted in 3 patients (10.3 %) at 3 years, none ankylosed (Grade IV). Postoperative improvement in patient-reported outcomes was significant ( p