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-   -   How to get into a trial or clinical study? (https://www.adrsupport.org/forums/showthread.php?t=6241)

ChainedJane 05-05-2008 05:03 PM

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

chasswen 05-07-2008 11:30 AM

just find a doctor whom is in the study. and pay him or her a visit. and ask it's that easy.

LBP 05-07-2008 02:04 PM

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.

Slackwater 05-07-2008 06:36 PM

Quote:

Originally posted by ChainedJane:

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?
~~~~~~~~~~~~~~~~~~~~~~~~~~~
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

Slackwater 05-08-2008 02:15 PM

Quote:

Originally posted by Slackwater:
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]
~~~~~~~~~~~~~~~~~~~~~~~~~~~

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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