Title: Clinical Outcomes Following Single-level, Two-level and Hybrid Lumbar Total Disc Replacement at a Single Canadian Institution
Authors: Jonathan Bourget-Murray, MD, Godefroy Hardy St-Pierre, MD, FRCSC, Jacques Bouchard, MD, FRCSC
Lumbar total disc replacements (TDR) have been used in clinical practice for over 20 years. Despite large American FDA studies having shown their non-inferiority to spinal fusion for the treatment of degenerative disc disease (DDD), there remains limited evidence on long-term functional outcomes and patient satisfaction rates following surgery. With a strict patient selection, TDR may provide successful improvement in patient’s pain profile and function by preserving intervertebral motion. This study aims to evaluate the clinical outcomes of a single surgeon’s patients who have undergone either single-level, two-level or hybrid (TDR and ALIF) lumbar TDR.
Patients will show improved functional outcomes following lumbar TDR. There will be limited complications and re-operations.
Retrospective analysis of prospectively collected data.
All patients had a single- or two-level lumber TDR, or a hybrid construct implanted between 2003-2015 by the senior author at the Foothills Medical Center. Twenty-four variables will be collected: age, sex, level of implant, prostheses type, pre-operative pain duration, narcotic use, medical comorbidities, psychiatric comorbidities, neurological deficit, BMI, lower extremity (LE) radicular pain, back dominant pain, smoking history, prior spine surgery, spinal injections, indications for surgery, work status, disability status, litigation, visual analogue scale (VAS) for low back pain and LE pain, Oswestry Disability Index (ODI), blood loss per-op and length of follow-up. All patients will be contacted by phone for follow-up and evaluated using a VAS to rate their LE and low back pain (10-point scale), ODI, need for re-operation, and overall satisfaction (yes/no-point scale).
Data & Analysis:
The primary outcomes to be analyzed are changes in pre- and post-operative VAS (Back and LE), ODI scores and post-operative complications as well as reoperation rate. Secondary outcomes include patient satisfaction and all prior outcomes reported individually. We will conduct a multivariate analysis via the random forest method. Mann-Whitney U test and Fisher exact test will be used to qualify relationship between variables.
No financial resources will be required for this study. JBM will conduct all phone follow-ups. JBM and GHS will analyze the data. We hope to have this study completed and manuscript written by June 2016.
In strictly selected patients, lumbar TDR could provide significant pain relief as well as improve function. This implant may be an alternative to spinal fusion.
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Author disclosures: None