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
Antoine G. Tohmeh, William D. Smith
April 2015, Volume 24, Issue 3, pp 331 - 338 Original Article Read Full Article 10.1007/s00586-015-3843-z
First Online: 21 March 2015
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 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 < 0.01 for all measures) and maintained through 3-year follow-up. Satisfaction with results was reported by 85 % (51/60) of patients at 2 years and 93 % (28/30) at 3 years. There were no revisions through 3 years postoperative.
The results following XL TDR show good clinical and radiographic outcomes out to 3 years postoperative, with clinically significant improvements in pain, function, and general health, few complications, and high patient satisfaction.
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