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Direct Comparison of Two Lumbar Total Disc Replacement Devices: Results from a Prospective, Randomized, Multicenter FDA-Regulated Trial
Proceedings of the NASS 25th Annual Meeting / The Spine Journal 10 (2010) 1S–149S The most frequently treated single-level was L5-S1 (64.2%). Of multilevel cases, two levels were most common (21.5%), with L5-S1 being the most frequent (68.5%). The baseline mean ODI score of 48.7 points improved significantly at 3 months (30 points; p!0.001) and maintained this improvement at all follow-up time points. At 3 months, the average VAS pain intensity score showed significant improvement from baseline and maintained similar improvement out to 8 years (baseline: 7.6 mm; 3 months: 2.3 mm; p!0.01). SF-36 scores indicated improvement in the physical (PCS) component at 12 months and remained similar at all subsequent follow-up points (baseline: 31.6; 12 months; 38.4; p!0.01); the mental (MCS) component stayed consistent at all time points. Radiographic evaluation demonstrated that functional range of motion was preserved at all levels out to 8 years. CONCLUSIONS: This longer term investigation shows clinical outcomes of the ProDiscÒ-L TDR past the 5-year follow-up point are maintained and provide significant improvement for patients. These results support earlier reports that ProDiscÒ-L is a safe and effective surgical treatment of discogenic pain in patients who meet the study criteria. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs. doi: 10.1016/j.spinee.2010.07.034
23. Lumbar Decompression Followed By CoflexÔ Interlaminar Implant vs. Pedicle Screw Posterior Lateral Fusion for Treatment of Stenosis Kenneth A. Pettine, MD; The Spine Institute, Loveland, CO, USA
11S
24. Direct Comparison of Two Lumbar Total Disc Replacement Devices: Results from a Prospective, Randomized, Multicenter FDARegulated Trial Richard D. Guyer, MD1, Kenneth A. Pettine, MD2, Reginald Q. Knight, MD3, Thomas A. Dimmig, MD4, Dom Coric, MD5, Paul C. McAfee, MD6, Charley Gordon, MD7, Andrew Cappuccino, MD8, Rudolph Buckley, MD9, Pierce Nunley, MD10, Fred Geisler, PhD11, Timothy A. Peppers, MD12, James Rappaport, MD13, Gary Dix, MD14, Wayne K. Cheng, MD15, Serena Hu, MD16, Yu-Po Lee, MD17, Fabien D. Bitan, MD18, Ravinder Bains, MD19; 1Texas Back Institute, Plano, TX, USA; 2Rocky Mountain Associates in Orthopedic Medicine, Loveland, CO, USA; 3Orthopedics International Spine, Seattle, WA, USA; 4 Triangle Orthopaedics Associates, Durham, NC, USA; 5Carolina Neurosurgery and Spine Associates, Charlotte, NC, USA; 6Orthopaedic Associates, P.A., Baltimore, MD, USA; 7Gordon Spine Associates, Tyler, TX, USA; 8Buffalo Spine Surgery, Lockport, NY, USA; 9Slocum Dickson Medical Group, New Hartford, NY, USA; 10Spine Institute of Louisiana, Shreveport, LA, USA; 11Illinois Neuro-Spine Center, Aurora, IL, USA; 12 CORE Orthopaedic Medical Center, Encinitas, CA, USA; 13Sierra Regional Spine Institute, Reno, NV, USA; 14Maryland Brain and Spine Center, Annapolis, MD, USA; 15Loma Linda University, Loma Linda, CA, USA; 16University of California San Francisco, San Francisco, CA, USA; 17 University of California San Diego, San Diego, CA, USA; 18Manhattan Orthopaedics, P.C., New York, NY, USA; 19Kaiser Oakland Spine Surgery, Oakland, CA, USA
BACKGROUND CONTEXT: This is Class I data from four FDA IDE sites on the clinical results of the Coflex Interlaminar Implant. PURPOSE: To compare the clinical safety and efficacy of CoflexÔ Interlaminar Fixation vs. instrumented fusion following standard decompression for lumbar stenosis. STUDY DESIGN/SETTING: Patients were part of a prospective randomized IDE clinical trial. PATIENT SAMPLE: Every patient underwent one or two level decompression followed by placement of a Coflex Interlaminar implant vs. pedicle screw fixation with posterior lateral bone graft. Inclusion and exclusion criteria will be discussed along with patient demographics. OUTCOME MEASURES: Clinical success was based on an improvement of at least 15 points in the ODI at 24 months compared to baseline, no re-operations, revisions, removals or supplemental fixation and no major device-related complications. METHODS: A prospective randomized comparison of Coflex vs. fusion from four FDA IDE sites are reported. Randomization was 2:1 Coflex vs. fusion. Follow up was completed at 6 weeks, 3 months, 6 months, and one year with physical exam, SF -12, VAS, ODI, and radiographic analysis. RESULTS: 28 one level surgeries (19 Coflex and 9 Fusion) and 11 two level surgeries (8 Coflex and 3 Fusion). Average pre-op ODI in the Coflex group was 55 (range 40 to 70). Average pre-op ODI in the fusion group was 59 (range 42–72). Post-op ODI in the Coflex group was 10.5 (range 0–40) a 81% improvement. Post-op ODI in the fusion group was 34.8 (range 14–56) a 41% improvement. Pre-op VAS in the Coflex group was 74.2 (range 56–94). Average pre-op VAS in the fusion group was 73.5 (range 64–90). Post-op VAS in the Coflex group was 15.2 (range 0–68) a 80% improvement. Post-op VAS in the fusion group was 34.2 (range 11–66) a 53% improvement. CONCLUSIONS: Both the Coflex and the fusion groups demonstrated safety with no device related complications and no reoperations or revisions. Both groups showed statistical improvement in ODI and VAS at follow up. The subjects randomized to Coflex demonstrated statistical superiority in all clinical measurements compared to fusion. FDA DEVICE/DRUG STATUS: Coflex: Investigational/Not approved.
BACKGROUND CONTEXT: Randomized trials have reported total disc replacement (TDR) to produce results similar or superior to lumbar fusion. Reported results for various TDRs appear to be similar, but differences in study design and outcome measures pose challenges in definitively comparing devices. PURPOSE: The purpose of this study was to perform a direct comparison of two lumbar TDRs in a prospective, randomized trial. STUDY DESIGN/SETTING: This study was a prospective, randomized, multicenter FDA-regulated trial designed to compare two lumbar TDR devices. PATIENT SAMPLE: TDR was performed in 457 patients from 21 sites (261 subjects in the investigational group (Kineflex Disc; metal-on-metal design, 204 randomized and 57 non-randomized training cases), and 196 in the control group (Charite´ Artificial Disc; metal with polyethylene core; 190 randomized and 6 non-randomized training cases). All patients were treated for single-level symptomatic disc degeneration of at least 6 months duration and unresponsive to non-operative treatment. OUTCOME MEASURES: Outcome measures included the Oswestry Disability Index, visual analog scale (VAS) assessing pain intensity, patient satisfaction, re-operation, and an overall measure of success defined to be at least 25% improvements in Oswestry scores, no re-operation, and no major adverse events. METHODS: After enrollment, patients were randomly assigned to the investigational or control group. Data were collected prospectively pre-operatively and at 6 weeks, and 3, 6, 12, and 24 months post-operatively. RESULTS: There were no significant differences between the groups when comparing operative time, blood loss, or length of hospital stay. Both groups improved significantly on Oswestry and VAS scores (p!0.01; see table) with no differences between the groups. Success rates were similar (75.5% investigational vs. 73.5% control). At 24-month follow-up, 94.1% of the investigational group and 91.9% of controls were satisfied with outcome. Re-operation was performed in 5.4% of the investigational group and 6.6% of controls. CONCLUSIONS: This prospective, randomized, controlled study comparing two TDRs, the first to the authors’ knowledge, found the devices produced very similar clinical outcomes. Both groups improved significantly by 6 weeks post-operative and remained improved throughout follow-up with a high patient satisfaction rate. FDA DEVICE/DRUG STATUS: Kineflex-L: Investigational/Not approved; Charite: Approved for this indication.
doi: 10.1016/j.spinee.2010.07.035
doi: 10.1016/j.spinee.2010.07.036
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.
23. Lumbar Decompression Followed By CoflexÔ Interlaminar Implant vs. Pedicle Screw Posterior Lateral Fusion for Treatment of Stenosis Kenneth A. Pettine, MD; The Spine Institute, Loveland, CO, USA
11S
24. Direct Comparison of Two Lumbar Total Disc Replacement Devices: Results from a Prospective, Randomized, Multicenter FDARegulated Trial Richard D. Guyer, MD1, Kenneth A. Pettine, MD2, Reginald Q. Knight, MD3, Thomas A. Dimmig, MD4, Dom Coric, MD5, Paul C. McAfee, MD6, Charley Gordon, MD7, Andrew Cappuccino, MD8, Rudolph Buckley, MD9, Pierce Nunley, MD10, Fred Geisler, PhD11, Timothy A. Peppers, MD12, James Rappaport, MD13, Gary Dix, MD14, Wayne K. Cheng, MD15, Serena Hu, MD16, Yu-Po Lee, MD17, Fabien D. Bitan, MD18, Ravinder Bains, MD19; 1Texas Back Institute, Plano, TX, USA; 2Rocky Mountain Associates in Orthopedic Medicine, Loveland, CO, USA; 3Orthopedics International Spine, Seattle, WA, USA; 4 Triangle Orthopaedics Associates, Durham, NC, USA; 5Carolina Neurosurgery and Spine Associates, Charlotte, NC, USA; 6Orthopaedic Associates, P.A., Baltimore, MD, USA; 7Gordon Spine Associates, Tyler, TX, USA; 8Buffalo Spine Surgery, Lockport, NY, USA; 9Slocum Dickson Medical Group, New Hartford, NY, USA; 10Spine Institute of Louisiana, Shreveport, LA, USA; 11Illinois Neuro-Spine Center, Aurora, IL, USA; 12 CORE Orthopaedic Medical Center, Encinitas, CA, USA; 13Sierra Regional Spine Institute, Reno, NV, USA; 14Maryland Brain and Spine Center, Annapolis, MD, USA; 15Loma Linda University, Loma Linda, CA, USA; 16University of California San Francisco, San Francisco, CA, USA; 17 University of California San Diego, San Diego, CA, USA; 18Manhattan Orthopaedics, P.C., New York, NY, USA; 19Kaiser Oakland Spine Surgery, Oakland, CA, USA
BACKGROUND CONTEXT: This is Class I data from four FDA IDE sites on the clinical results of the Coflex Interlaminar Implant. PURPOSE: To compare the clinical safety and efficacy of CoflexÔ Interlaminar Fixation vs. instrumented fusion following standard decompression for lumbar stenosis. STUDY DESIGN/SETTING: Patients were part of a prospective randomized IDE clinical trial. PATIENT SAMPLE: Every patient underwent one or two level decompression followed by placement of a Coflex Interlaminar implant vs. pedicle screw fixation with posterior lateral bone graft. Inclusion and exclusion criteria will be discussed along with patient demographics. OUTCOME MEASURES: Clinical success was based on an improvement of at least 15 points in the ODI at 24 months compared to baseline, no re-operations, revisions, removals or supplemental fixation and no major device-related complications. METHODS: A prospective randomized comparison of Coflex vs. fusion from four FDA IDE sites are reported. Randomization was 2:1 Coflex vs. fusion. Follow up was completed at 6 weeks, 3 months, 6 months, and one year with physical exam, SF -12, VAS, ODI, and radiographic analysis. RESULTS: 28 one level surgeries (19 Coflex and 9 Fusion) and 11 two level surgeries (8 Coflex and 3 Fusion). Average pre-op ODI in the Coflex group was 55 (range 40 to 70). Average pre-op ODI in the fusion group was 59 (range 42–72). Post-op ODI in the Coflex group was 10.5 (range 0–40) a 81% improvement. Post-op ODI in the fusion group was 34.8 (range 14–56) a 41% improvement. Pre-op VAS in the Coflex group was 74.2 (range 56–94). Average pre-op VAS in the fusion group was 73.5 (range 64–90). Post-op VAS in the Coflex group was 15.2 (range 0–68) a 80% improvement. Post-op VAS in the fusion group was 34.2 (range 11–66) a 53% improvement. CONCLUSIONS: Both the Coflex and the fusion groups demonstrated safety with no device related complications and no reoperations or revisions. Both groups showed statistical improvement in ODI and VAS at follow up. The subjects randomized to Coflex demonstrated statistical superiority in all clinical measurements compared to fusion. FDA DEVICE/DRUG STATUS: Coflex: Investigational/Not approved.
BACKGROUND CONTEXT: Randomized trials have reported total disc replacement (TDR) to produce results similar or superior to lumbar fusion. Reported results for various TDRs appear to be similar, but differences in study design and outcome measures pose challenges in definitively comparing devices. PURPOSE: The purpose of this study was to perform a direct comparison of two lumbar TDRs in a prospective, randomized trial. STUDY DESIGN/SETTING: This study was a prospective, randomized, multicenter FDA-regulated trial designed to compare two lumbar TDR devices. PATIENT SAMPLE: TDR was performed in 457 patients from 21 sites (261 subjects in the investigational group (Kineflex Disc; metal-on-metal design, 204 randomized and 57 non-randomized training cases), and 196 in the control group (Charite´ Artificial Disc; metal with polyethylene core; 190 randomized and 6 non-randomized training cases). All patients were treated for single-level symptomatic disc degeneration of at least 6 months duration and unresponsive to non-operative treatment. OUTCOME MEASURES: Outcome measures included the Oswestry Disability Index, visual analog scale (VAS) assessing pain intensity, patient satisfaction, re-operation, and an overall measure of success defined to be at least 25% improvements in Oswestry scores, no re-operation, and no major adverse events. METHODS: After enrollment, patients were randomly assigned to the investigational or control group. Data were collected prospectively pre-operatively and at 6 weeks, and 3, 6, 12, and 24 months post-operatively. RESULTS: There were no significant differences between the groups when comparing operative time, blood loss, or length of hospital stay. Both groups improved significantly on Oswestry and VAS scores (p!0.01; see table) with no differences between the groups. Success rates were similar (75.5% investigational vs. 73.5% control). At 24-month follow-up, 94.1% of the investigational group and 91.9% of controls were satisfied with outcome. Re-operation was performed in 5.4% of the investigational group and 6.6% of controls. CONCLUSIONS: This prospective, randomized, controlled study comparing two TDRs, the first to the authors’ knowledge, found the devices produced very similar clinical outcomes. Both groups improved significantly by 6 weeks post-operative and remained improved throughout follow-up with a high patient satisfaction rate. FDA DEVICE/DRUG STATUS: Kineflex-L: Investigational/Not approved; Charite: Approved for this indication.
doi: 10.1016/j.spinee.2010.07.035
doi: 10.1016/j.spinee.2010.07.036
All referenced figures and tables will be available at the Annual Meeting and will be included with the post-meeting online content.