444 - Freedom Disc vs. ProDisc-L for Treatment of 1-level Lumbar Disc Diseas...

#444 Freedom Disc vs. ProDisc-L for Treatment of 1-level Lumbar Disc Disease: Results from One Investigative Site of the USA FDA Randomized Clinical Trial

Oral Posters: Lumbar

Presented by: H. Bedi

Author(s):

H. Bedi (1)
M. Kropf (1)
L.E.A. Kanim (1)
J. Kim (1)
B. Hyun (1)
A. Rasouli (1)
R.B. Delamarter (1)

(1) Spine Center, Cedars-Sinai Medical Center, Department of Surgery, Los Angeles, CA, USA

Abstract

Introduction: The Freedom Artificial Disc was being studied in order to treat single-level lumbar disc disease L3 to S1. This was a randomized controlled trial (USA-FDA-RCT) to compare safety and outcomes between patients treated with one of two artificial disc replacement devices (ADR): the Freedom® Lumbar Disc compared to the ProDisc-L ('standard of care') which is USA FDA approved to treat one-level disc disease. The design of the Freedom Artificial Disc allows potentially less range of motion in flexion, extension, axial rotation, and translation than does the ProDisc-L.

Objective: To assess the clinical patient self-reported outcomes for patients treated for single-level lumbar disc with the Freedom® Disc compared to 'standard treatment' with ProDisc-L. To report the two year results of a RCT comparison after treatment using two ADRs.

Methods: The USA-FDA approved clinical trial study of the Freedom® Lumbar Disc (AxioMed Spine Corp., Cleveland, OH) versus ProDisc-L (Synthes, West Chester, PA) was a prospective, randomized [1 (Freedom®, FD) : 1 (ProDisc-L, PD)]. Self-reported inventories of Visual Analog Scale for back pain (VAS back pain) and VAS leg pain, Oswestry disability Index, and range of motion (ROM) were collected preoperatively and at 6 weeks, 3, 6, 12, 18, and 24 months annually postoperatively. Physical Exams (PE) and Adverse Events (AE) were systematically collected. Up to 2 years of data were available and reported herein.

Results: Data were available for 39 of 43 patients treated with Freedom Disc (20 1-level) vs. ProDisc-L (19 1-level). For Freedom patients, significant improvements of 80% in VAS back pain (FD: 7.3 pre vs 1.5 x 24mo), 86% in VAS leg pain (FD:2.7 pre to 0.3 at 24 mo) and 74% in Oswestry disability (FD:59.5 pre vs. 14.2 24mo) were observed by 6 weeks and well maintained to 24 months (p< 0.05). For ProDisc-L treated patients, significant improvements of 68% in VAS back pain (PD: 7.3 pre vs 2.5 x 24mo), 60% in VAS leg pain (FD 3.9 pre to 1.8 at 24 mo) and 63% in Oswestry disability (FD: 57.1 pre vs. 21.2 at 24mo) were observed by 6 weeks and well maintained to 24 months. There was a slight early treatment benefit for Freedom noted by 6 wks [VAS back: 2.6 (FD) vs 4.2 (PD) at 6wks, p< 0.02; 2.3 (FD) vs 3.9 (PD) at 3 mo,p< 0.04, and 1.5 (FD) vs 3.8 (PD) at 6 mos p< 0.001; ODI: 19.3 (FD) vs 30.5 (PD) at 6 mos, p< 0.02] that disappeared at longer follow-up (NS).

Conclusions: Significant recovery was similarly reported by patients after a disc replacement using either the Freedom or ProDisc-L ADR. Improvements in patients' self-reported outcomes were found as early as 6 weeks; improvements were maintained up to 24 months. Slightly earlier recovery was self-reported by Freedom ADR treated patients than by ProDisc-L treated patients. This benefit was no longer observed after 6 months.