Study finds, Outcomes of Trial for Lumbar Artificial Discs i
This study compared 7-year safety and efficacy outcomes of activL and ProDisc-L lumbar total disc replacements in patients with symptomatic, single-level lumbar degenerative disc disease (DDD). The objectives are to report 7-year outcomes of the trial, evaluate the outcomes for patients lost to follow-up, and determine whether early outcomes predict long-term outcomes.

This was a prospective, multicenter, randomized, controlled investigational device exemption study. Eligible patients with symptomatic, single-level lumbar DDD had failed more than 6 months of nonsurgical management. Patients (N = 283) were randomized to receive activL (n = 218) or ProDisc-L (n = 65). At 7 years, data were available from 206 patients (activL, 160; ProDisc-L, 46).

Results:
--At 7 years, the activL group was noninferior to the ProDisc-L group on the primary composite endpoint.

--Both groups showed significant reductions in back/leg pain severity and improvements in disability index and quality-of-life relative to baseline.

--In both groups, opioid use was significantly reduced at 7 years (0%) relative to baseline and the overall reoperation rates were low (4.6%).

--activL patients showed a significantly better range of motion for flexion-extension rotation than ProDisc-L patients.

--A significantly higher proportion of activL patients did not report serious adverse events.

--Predictive modeling indicated that more than 70% of patients lost to follow-up after 2 years would show clinically significant improvement at 7 years if improvements were achieved at 2 years.

Finally, after 7 years, the effects of activL and ProDisc-L are still present, with considerable improvements in pain, function, and opiate usage as compared to baseline. activL is more effective in preserving ROM than ProDisc-L and has a superior safety profile. In both disc configurations, other primary and secondary outcomes improved in a similar fashion.

Source: http://www.ijssurgery.com/content/early/2021/07/12/8083
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