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| The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here. |
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#11
07-21-2005, 12:48 AM
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Point of View: Commentary on the Research Reports that Led to Food and Drug Administration Approval of an Artificial Disc [Editorial] Mirza, Sohail K. MD, MPH 1. Charite was implanted into patients after strong clinical evidence and FDA approval, unlike some other technologies that came to the market previously (cages, rods, pedicle screws, hooks, etc.) 2. Charite was compared to Anterior Lumbar Interbody Fusion with BAK cages: the writer of the article states that the Charite was compared to an operation that has largely been abandoned because surgeons saw it fail frequently firsthand. He goes on to state that few surgeons now do anterior interbody fusions with stand alone cages. 3. Meager success rate in both Charite and fusion groups. Success rate for Charite is based on four modest criteria: 1) Owestry disability score @ 24 months post-op 2) no device failure 3) no major complication and no 4) neurological deterioration. ----> for the FDA study these are "ideal" patients that went through many levels of screening to be included in the study. ---->64% of the successful ADR patients at 2 years post-op were still using narcotic meds for pain 4. Safety in the two studies (I have links above in this thread) are incomplete. 5. The expert spine surgeons in the IDE study submitted to the FDA implanted 17% of the devices in a suboptimal location in subsequent randomized patients. ----> separating approach-related and device-related complications makes the device appear safer than it may really be. 6. 39% of the 178 patients had a range of motion of 5 degrees and less at the implantation site--study authors acknowledge that is range is within the FDA definition of fusion. ----> An orthopedic and rehabilitation panel asked the FDA to view these cases as failures. The FDA disagreed and said that range of motion was not a definition of success in the Charite study. 7. 2500 surgeons trained, 120 currently training each week, and the training schedules are booked for the next six months (Charite training). 8. Marketing slogans such as "Natural motion of the spine is back" implies that the ADR creates a normal spine; it does not. Contray to marketing, the data submitted to the FDA and published in this issue of SPINE argue for caution by patients and surgeons. ---------------------------------------------------- "Editorial Response to Parts 1 and 2 of the FDA IDE Study of Lumbar Total Disc Replacement With the Charite[TM] Artificial Disc Vs. Lumbar Fusion"? Zindrick, Michael R. MD *; Lorenz, Mark A. PhD *; Bunch, Wilton H. MD, PhD *+ Institution From the *Department of Orthopaedics and Rehabilitation, Loyola University, Chicago, IL, and +Beeson Divinity School, Samford University, Birmingham, AL. Editorial Response to Parts 1 and 2 of the FDA IDE Study of Lumbar Total Disc Replacement With the Charite[TM] Artificial Disc Vs. Lumbar Fusion.[Editorial] Spine. 30(14):E388-E390, July 15, 2005 1. In a clinical setting there is no class I, II, or II (it says II twice) that supports the assumption that fusion accelerates adjacent segment disease.---> A longitudinal study documented the normal aging process in the lumbar region of a nonoperative spine. The authors noted a worsening of radiographic evidence for progressive osteoarthritis of 3-4% a year (without correlation to clinical symptoms). The authors state that this percentage is the same percentage quoted for risk of adjacent segment disease progression after fusion. 2. The authors of the two IDE studies should be congratulated for presenting the 1st controlled of ADR. Before the authors study, only a limited number of studies have been published--representing only 10% of the 9000 Charites implanted worldwide (in 30 countries in the last 18 years). 3. Charite study was in an effort to gain FDA approval and bring it to market. The study was performed to display noninferiority of the Charite to BAK fusion. 4. BAK fusion was used because it was the only FDA approved anterior cage at the time of the Charite study. The stand-alone BAK cage with iliac crest bone graft may not be the optimal choice by today's standards = comparing Charite to inferior surgery. 5. Charite mean range of motion 7.1 degrees--FDA acknowledges <5 degrees of motion as a fusion, 25% of the Charite patients met the FDA definition for fusion after operation with the Charite. 6. Less than ideal placement of the prothesis compromises quality of motion, and, therefore clinicial outcome. 7. Misplacement leads to abnormal loads on the facet joints, prothetic core, remaining soft tissue of annulus, facet capsule, and posterior spinal ligaments. 8. Those participating in study wanted to have the Charite implanted as they thought it was as good or better than fusion. After surgery, there would be those disappointed that did not receive the Charite and relief from those that received the Charite. ----> the conclusion of those that expressed satisfaction at the 24 mo check up and would have the treatment again with the Charite is invalid without analysis to study decliners (whom underwent fusion as their primary choice). 9. Hospital stay with Charite is shorter--there was no standardization or protocal for study so there is no credence to this claimed benefit. 10. Authors of the IDE study claim that the return to work for Charite recipients was higher--there was no statistical return-to-work status between the fusion and Charite group. 11. Less subsidence with Charite--the surface area for the Charite on the endplate is substantially larger than the BAK cage (BAK cage only rests on very small total surface area on the endplate), resulting in less force per area on the endplate--author states this is a dubious point made by the IDE study investigators. 12. Two studies are cited that counter that ADR protects against adjacent segmental degeneration--van Ooij (our friend  ) and Phillips. Phillips found after 2 years with the Charite that 44% of patients showed progression of facet degeneration with MRI images.13. Longer study (longer than 2 years) need to be done to establish efficacy and widespread use. 14. Studies of poly debrib on long term use are needed as there is not evidence about long-term effects of poly debris on neural tissues. 15. Evidence in previous studies of osteolysis and core wear--how will this affect the longevity of the prosthesis? 16. Reoperation because of continued pain, implant displacement, wear debris, or loosening can prove difficult even in experienced hands (revision with posterior fusion does not relieve pain in all patients). 17. Some surgeons have already reported discontinuing multilevel implantation as a result of poor results. (Cinotti G, David T, Posticchini F. Results of disc prosthesis after a minimum follow-up period of 2 years. Spine 1996;21:995�1000.)---> it is ethically questionable to expand use beyond FDA approval. 18. The most important information on long-term success of the Charite will be based on the 5, 10, 15 year follow-ups with the IDE study patients. 
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