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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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#1
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Hi all,
Just curious how patients end up in trials and clinical studies? How would one go about finding out if they could join a study and if you do become part of a trial do they cover the medical costs? Thanks, Janey
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*c/6-c/7 herniated disc /pinching nerve causing extreme and radiating pain in back-neck and nubness in left arm and compressing spinal cord from 13mm to 6 mm- cervical steriod injections-physical therapy-lots of meds-* CIGNA insurance revoked my F |
#2
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just find a doctor whom is in the study. and pay him or her a visit. and ask it's that easy.
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ddd 1990 2003 mri,xrays,shots,emg 2004 discogram ouch pos l4 l5 facet block neg lost all appeals BCBS 5 months of that 3 surgeons later surgery with dr. bertagnoli aug 2nd 2006 in Bogen Germany Successfully ProDisc-L L-4 L-5 |
#3
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go to http://www.spine-health.com/Clinical-Trials.html
Look at what trials are active, see if you meet the criteria and then see which doctors/facilities are participating and make a consultation appointment letting them know you are interested in being a participant in their trial. If you hear that there's a trial starting but it's not officially announced, you can sometimes contact the manufacturer to find out which dr to contact closest to where you live. sometimes if you're lucky your regular treater is aware of an active trial and will refer you but that is not the only way to get in.
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Injured 9/01 Annular tears L4/5 & L5/S1 denied adr by insurance for 2 level charite as well as hybrid fusion at L5/S1 with Charite at L4/5. New ins paid for 2 level lumbar prodisc surgery on 4/7/08 (at age 39) with Dr. Westerlund, at Core Orthop |
#4
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Quote:
Clinical Trials.Gov A Service of the U.S. National Institutes of Health Click This Link: Four (4) clinical trials are recruiting, minimally, based on a search using "cervical spine artificial disc" on ClinicalTrials.gov<UL TYPE=SQUARE>Advent™ Cervical Disc Versus Anterior Cervical Discectomy and Fusion(ACDF)(link) DISCOVER™ Artificial Cervical Disc and ACDF (link) Kineflex-C Artificial Disc System to Treat Cervical Degenerative Disc Disease (link) NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease (link)[/list]~~~~~~~~~~~~~~~~~~~~~~~~~~~ You asked:<UL TYPE=SQUARE>How: meet inclusion criteria, avoid exclusion criteria Join: see participating surgeon near you Cost: don't know[/list]May I please ask, do you have a device preference? Clinical Trials are "randomized" (ie. ADR or Fusion). You might select based on surgeon training, availability, of the Cervical ADR . TDR . TDA devices on the FDA list of approved, or approvable with conditions(*).<UL TYPE=SQUARE>Prestige® Cervical Disc Prodisc™-C Disc Bryan®*[/list]CIGNA has a coverage position for 1-level lumbar ADR. CIGNA will not cover: a. 1-level lumbar ADR with 1-level fusion (hybrid), or b. 2-level lumbar ADR. Slackwater cigna, mva: 2-level lumbar surgical candidate
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---------------------------------------------------------- slackwater_sf 2004 MVA, 2-level lumbar surgical candidate |
#5
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Quote:
M6™-C Artificial Cervical Disc is in actually in FDA Clinical Trial; it is missing from above FDA list. M6™-C is CE marked (European Union ?approved?) per Orthopaedic Product News. M6™-C is made by Spinal Kinetics of California. Please see M6™-C Artificial Cervical Disc Design is First to Replicate Natural Disc with Artificial Nucleus and Annulus. on ADRSupport.org, or BusinessWire. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I called the company and left v.mail, nobody answered, about a possible lumbar design, but no response (NR). NR is to be expected. Slackwater mva: 2-level lumbar surgical candidate
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---------------------------------------------------------- slackwater_sf 2004 MVA, 2-level lumbar surgical candidate |
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