Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results.

Background: 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.

Methods: This was a prospective, multicenter, randomized, controlled investigational device exemption study.

Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease.

Study Design: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.

Objective: The aim of this study was to compare the 5-year safety and effectiveness of the activL Artificial Disc with Control Total Disc Replacement (TDR) systems (ProDisc-L or Charité) in the treatment of patients with symptomatic single-level lumbar degenerative disc disease (DDD).

Summary Of Background Data: The activL Artificial Disc received Food and Drug Administration approval in 2015 based on 2-year follow-up data.

Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up.

Background: Cervical total disc replacement (TDR) is an increasingly accepted procedure for the treatment of symptomatic cervical degenerative disc disease. Multiple Level I evidence clinical trials have established cervical TDR to be a safe and effective procedure in the short-term. The objective of this study is to provide a long-term assessment of TDR versus anterior discectomy and fusion for the treatment of one- and two-level disc disease.

Are patient-reported outcomes predictive of patient satisfaction 5 years after anterior cervical spine surgery?

Background Context: Patient satisfaction is becoming an increasing common proxy for surgical quality; however, the correlation between patient satisfaction and surgical outcomes 2 and 5 years after anterior cervical surgery has not been evaluated.

Purpose: The study aimed to determine if patient satisfaction is predicted by improvement in patient-reported outcomes (PRO) 2 and 5 years after anterior cervical spine surgery.

Study Design: This is a retrospective analysis of prospectively collected data.

Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial.

Study Design: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.

Objective: The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.

Summary Of Background Data: Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability.

Spine care: evaluation of the efficacy and cost of emerging technology.

Over the last decade a number of new technologies have been introduced to the area of spine care. Although this recent explosion of innovation has brought advances to patient care, it has also brought concerns regarding overuse, increasing costs, and safety. A value-based approach to assessing and purchasing new technology depends on a shift toward comparative effectiveness analysis, transparency in pricing and potential conflicts of interest, and an alignment of incentives and goals among purchasers, consumers, and payers.