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
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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