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-   -   Clinical Trials (https://www.adrsupport.org/forums/showthread.php?t=6804)

Harrison 12-09-2006 10:15 AM

Cervical & Lumbar Artificial Disc Replacement

PCM® Artificial Cervical Disc Replacement Trial
http://www.discstudy.com/

Kineflex|C™ Cervical Artificial Disc Implant
Kineflex™ Lumbar Artificial Disc Implant
http://www.spinalmotion.com/

Mobi-C Cervical Disc
http://www.ldrspine.com/secondgenera..._dev_desc.html
Note: Randomized (2:1)trial; 1 and 2 level study

FlexiCore® Lumbar Intervertebral Disk Replacement
CerviCore™ Intervertebral Disc
http://www.stryker.com/spine/product...vation_fc.html

SECURE®-C Cervical Artificial Disc
http://www.globusmedical.com/clinica...cal_trials.php

Discover™ Artificial Cervical Disc
http://www.johnsoncountyspine.com/pages/depuy.php

ProDisc Cervical
http://us.synthesprodisc.com/EN-US/D...oDiscCervical/

Active L Disc Replacement
Note: Trials under way across the U.S.
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Facet Replacement

TFAS™ Total Facet Arthroplasty System
http://www.archususa.com/Clinical.html

Anatomic Facet Replacement System (AFRS™)
http://www.facetsolutions.com/Overview.html
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Nucleus Repair & Replacement

Raymedica HydraFlex Nucleus Arthroplasty System
http://www.raymedica.com/us_trial.html

Spinal Restoration
http://www.spinalrestoration.com/technology.html

DASCOR™ disc nucleus replacement
http://www.discdyn.com/clinical_studies.html

NuCore™ Injectable Nucleus
http://www.spinewave.com/products/nucore.html

Nuvasive NeoDisc (cervical)
Note: IDE study was announced: http://www.neodiscstudy.com/index.htm See previous press release here.

NeuDisc Nucleus Replacement
Note: MFRed by Replication Medical Inc., trial dates unknown
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Bone Fractures & Osteoporosis

Treatment of Osteoporosis
See the Study Description and Qualifications here.
http://www.novartisclinicaltrials.com/webapp/portals/Os...isStudy/DoYouQualify

Cortoss Pivotal Trial (for vertebral compression fractures)
http://orthovitaportal.com/Cortoss%20Technical%20Inform...inicalTrials-US.aspx

Note: Kyphon also has a trial for treating osteoporotic vertebral body compression fractures, but it’s not listed on their web site.

Summary: Have you been diagnosed with osteoporosis or low bone mass?
http://www.centerwatch.com/patient/s...stu115176.html
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Stabilization

Dynamic Stabilization for Lumbar Spinal Stenosis with Stabilimax NZ® Dynamic Spine Stabilization System
http://clinicaltrials.gov/ct2/show/N...0479544&rank=1

DIAM Spinal Stabilization System,
Medtronic, see their site at http://www.back.com/articles-diam-stenosis.html

Wallis Stabilization System
Trial is now open, see http://clinicaltrials.gov/ct2/show/NCT00484458?cond=%22...Back+Pain%22&rank=92

All Other Related Trials

Lumbar Spinal Stenosis
Stabilimax NZ Dynamic Spine Stabilization System
www.appliedspine.com (Spring 07 trials across U.S.)

Synvisc Injections for Lumbar Facet Joint Pain
http://clinicaltrials.gov/ct/show/NCT00325845?order=110

Comparison of the Effectiveness of Mobilization and Manipulation of the Thoracic Spine in Patients With Mechanical Neck Pain
http://clinicaltrials.gov/ct/show/NCT00128869?order=2

Cliavist in Infectious and Degenerative Diseases of the Spine (French Study)
http://clinicaltrials.gov/ct/show/NCT00372281?order=1

Greenwich Lumbar Stenosis SLIP Study
http://clinicaltrials.gov/ct/show/NCT00109213?order=15

Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain (Norway)
http://clinicaltrials.gov/ct/show/NCT00201513?order=29

A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
http://clinicaltrials.gov/ct/show/NCT00265083?order=33

Rheumatoid arthritis, osteoarthritis, gout, ankylosing spondylitis, osteoporosis
http://www.arapc.com/clinicaltrials1.html
Trial specifics and update: http://www.arapc.com/rheumors/trials-update2004.pdf
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Please note: this information will be updated frequently. Though this is one of the most complete lists available (created expressly for this community), do not assume it is the only source of information. Email or call if you have specific questions.

Harrison 02-12-2007 09:30 AM

Three trials added today.

Harrison 07-03-2007 09:05 AM

Added the osteoporosis trial today.

Harrison 08-18-2007 08:28 AM

Added two new trials today, corrected the Wallis trial info (now open in multiple locations).

Harrison 05-30-2008 06:42 AM

Added the Stabilimax NZ Dynamic Spine Stabilization today. Thanks Liz!

Also created a category for stabilization and updated five outdated links. http://adrsupport.org/groupee_common...n_rolleyes.gif

Harrison 10-16-2009 02:10 PM

NuVasive Lumbar eXtreme Lateral Total Disc Replacement (XL TDR)
 
FDA Clinical Trial -- NuVasive Lumbar eXtreme Lateral Total Disc Replacement (XL TDR)

To Evaluate The Safety And Effectiveness of The Lumbar TDR Device In Patients With Single-Level Lumbar DDD (LTDR) (NuVasive)
http://clinicaltrials.gov/ct2/show/NCT00927238?term=nuvasive+lateral&rank=3

See additional info (including conditions treated, eligibility criteria and study locations) on the eXtreme Lateral Total Disc Replacement (XL TDR) on Nuvasive's website:
http://www.nuvasive.com/xlmotion/


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