In-depth information and clinical trials related to spine medicine and spine surgery, such as artificial discs, spine fusion and kyphoplasty.
This is a listing of industry-sponsored
clinical trials that are actively recruiting patients.
These clinical trial listings are not edited or peer-reviewed
by SpinesHealth.com.
Cervical artificial
disc clinical trial—PCM® (sponsored
clinical trial listing)
October 31, 2005
This is a multi-center, prospective, randomized, controlled
clinical trial comparing the safety and effectiveness
of the Porous Coated Motion (PCM®) disc
for the treatment of disc herniation(s) or other degenerative
disc disease (DDD) in the upper (cervical) spine as
compared to spinal fusion in the treatment of this
disease. Read more...
Cervical
artificial disc clinical trial—Kineflex-C™ (sponsored
clinical trial listing)
October 6, 2005
This is a multi-center, prospective, randomized, controlled clinical trial comparing
the safety and effectiveness of the Kineflex-C Spinal System to anterior cervical
discectomy and fusion surgery in relieving the symptoms associated with degenerative
disc disease in the cervical spine. Read
more...
Lumbar
artificial disc clinical trial—Kineflex™ (Sponsored
clinical trial listing)
September 6, 2005
This is a multi-center, prospective, randomized, controlled clinical trial comparing
the safety and effectiveness of the Kineflex Spinal System to the Charité Artificial
Disc implant in relieving the symptoms associated with degenerative disc disease
in the lumbosacral spine. Read more...
Wallis Stabilization
System Clinical Trial (sponsored
clinical trial listing)
March 7, 2005
The US Clinical Study of the Wallis Stabilization System is a multi-center prospective,
randomized clinical trial currently enrolling patients to compare the safety
and effectiveness of the Wallis Device, a non-fusion surgical device, to conservative
care for treatment of degenerative disc disease. Read
more...
Cervical
artificial disc clinical trial—PRODISC-C® (sponsored
clinical trial listing)
November 25, 2003
A multi-center, prospective, randomized, controlled clinical trial comparing
the safety and effectiveness of PRODISC-C to anterior cervical discectomy and
fusion surgery in the treatment of symptomatic cervical disc disease. Read
more...
Charité™ Artificial Disc
(sponsored clinical trial listing)
May 16, 2003
The Charité Artificial Disc is an investigational
device limited by US (Federal) law to investigational
use in the USA. Read
more...
Artificial
disc clinical trialPRODISC (sponsored clinical trial listing)
November 30, 2001
This is study is a multi-center, prospective, randomized,
controlled clinical trial comparing the safety and
effectiveness of PRODISC total disc replacement to
spinal fusion surgery in the treatment of discogenic
pain associated with degenerative disc disease (DDD)
in the lumbosacral spine.
Read more...
Rechargeable
spinal cord stimulators for chronic pain (Research
article)
September 23, 2005
Spinal cord stimulators are small devices implanted under a patient’s skin
with the purpose of stopping pain signals from reaching the brain and thus alleviating
chronic or neuropathic pain. They may be recommended if conservative treatments
fail to relieve chronic pain. Read
more...
By: Thomas M. Wascher, MD, FACS
Lumbar
Artificial Disc Surgery for Chronic Back Pain (Research
article)
August 4, 2005
An artificial disc offers several theoretical benefits over spinal fusion for
treatment of chronic back pain, including the potential for enhanced pain relief
and to avoid premature degeneration at adjacent levels of the spine. This article
provides an in-depth review of lower back disc replacement surgery and clinical
trials. Read
more...
By: Jack Zigler, MD
Disc
nucleus replacement as an alternative to artificial
disc replacement (Research
article)
June 14, 2005
Disc nucleus replacement is a new type of surgery for
low back pain from degenerative disc disease. Unlike
artificial disc replacement, which involves replacing
the entire disc, disc nucleus replacement surgery replaces
just the inner part of the disc. Read more...
By: John
Sherman, MD
Effectiveness of glucosamine
and chondroitin sulfate for osteoarthritis (Research
article)
April 19, 2005
Although there is not yet a proven treatment to stop or slow the progression
of osteoarthritis, glucosamine and chondroitin sulfate nutritional supplements
may provide a viable alternative for some patients. An FDA study on the effects
and safety of glucosamine and chondroitin dietary supplements is currently underway,
and many physicians support their use because of the low incidence of serious
side effects (compared to other medications, such as COX-2 inhibitors and other
NSAIDs). Read more...
By: Thomas E. Hyde, DC
Spinal disc
replacement with the CHARITÉ Artificial
Disc
Updated March 30, 2005
The goal of the CHARITÉ Artificial Disc replacement
surgery is to reduce or alleviate chronic low back
pain from degenerative disc disease by restoring the
intervertebral disc height and neuroforaminal height
while returning physiologic motion (similar to that
of a healthy disc) in that segment of the spine. This
artificial disc surgery requires complete removal of
the unhealthy disc in order to implant the new artificial
disc. Read more...
By: Paul McAfee, MD
All about the
Charité artificial disc: now approved for
use in the U.S.
November 17, 2004
Artificial disc replacement surgery is now available in the US for select patients
with ongoing back pain from degenerative disc disease. As with any new surgical
procedure, a number of factors should be considered before any patient has artificial
disc surgery, including the surgeon's relevant training, the surgeon's skills,
patient selection and appropriate indications, and more. Read
more...
By: Stephen Hochschuler, MD and Paul McAfee, MD
Preventing
post-laminectomy spinal deformity in children with
intramedullary spinal cord tumors
(Research
article)
May 5, 2004
The study found that instrumented spinal fusion as part of the same surgery to
remove the tumor was usually effective in preventing development of spinal deformity. Read
more...
By: John Dormans, MD, and Leslie Moroz, Research Coordinator
Artificial
disc for cervical disc replacement (Research article)
April 12, 2004
The intent of the artificial cervical disc device
is to preserve motion at the disc space. It is an alternative to the use of bone
grafts, plates and screws in pursuit of a fusion following removal of a cervical
disc. Read more...
By: Mark Mikles, MD and
Jeffrey A. Goldstein, MD
Bracing
for scoliosis found less effective for overweight
teens (Research article)
October 17, 2003
A recent study at Johns Hopkins Children's Center
has shown that bracing treatment for adolescent scoliosis
is significantly less effective for teenagers who are
overweight. Read more...
By: John Dormans, MD, and Leslie Moroz, Research Coordinator
Bone
graft substitutes for spinal fusion: August 2003
update
(Research article)
August 15, 2003
Significant advances in bone graft substitutes for spine
fusion have been made in the last couple of years, and
the Food and Drug Administration (FDA) has approved
a number of new products. Read
more...
By: Alexander R. Vaccaro, MD
The
Graston Technique: a new manual therapy for back pain
(Research article)
August 5, 2003
This form of manual therapy for back pain incorporates
the use of stainless-steel instruments. The goal of
the therapy is to separate and break down the scar tissue,
as well as stretch connective tissue and muscle fibers.
Read more...
By: Thomas E. Hyde, DC
Pneumatic
vest - a new lower back pain treatment option
(Research article)
May 28, 2003
Many patients with lower back pain feel worse with activity
that loads the spine (such as walking). For patients
who meet specific criteria there is a new treatment
that is designed to unload some of the weight from the
patient's lumbar spine, thus simulating a state of decreased
weight-bearing on the lower back. Read
more...
By: Andrew J. Cole, MD
PNT - a new, minimally
invasive treatment for lower back pain (Research article)
August 28, 2002
The treatment involves the delivery of electrical
stimulation directly to the deeper tissues (muscles,
ligaments, tendons) near the spine through several needle
electrodes. The theory is that this type of electrical
stimulation helps curtail the central nervous system
hypersensitivity that leads to persistent pain. Read
more...
By John Revord, MD
Electrical
stimulation for spinal fusion (Research article)
November 30, 2001
Electrical stimulation is designed to improve the effectiveness
of lumbar spinal fusion. As the number of studies validating
the use of this procedure grows, there is a better understanding
among spine surgeons about how and when to use it. Read
more...
By Neil Kahanovitz, MD
Does smoking cause
low back pain? (Research article)
July 31, 2001
A new study strengthens the link between smoking
and lower back pain, and also sheds light on the causes
of degenerative lumbar spine problems. Read
more...
By Donald Frisco, MD
Bone graft
substitutes for lumbar spine fusion surgery
(Research article)
February 7, 2001 (Updated
April 28, 2003)
There is a lot of interest in the spine community
to develop a bone graft substitute to use during lumbar
spinal fusion procedures. This article addresses several
viable alternatives. Read
more...
By: Scott D. Boden, M.D.
Research update on
IDET (Research article)
January 2, 2001
Two peer reviewed studies published in the October 2000
issue of SPINE Journal report on the outcomes of patients
having received Intradiscal Electrothermal Annuloplasty
(IDET) an average of one year after treatment. Read
more...
By Ari Ben-Yishay, MD
Osteoarthritis
treatments - Glucosamine and chondroitin sulfate supplements
(Research article)
November 29, 2000
For patients who have evidence of osteoarthritis
in their spine (as seen on an x-ray) and who have had
other causes of back pain and neck pain ruled out by
their health care provider, glucosamine sulfate and
chondroitin sulfate may be a treatment option. Read
more...
By Christopher D. Chaput, MD
Kyphoplastya new
treatment for osteoporotic fractures
(Research article)
July 7, 2000 (last updated August 14, 2003)
Kyphoplasty, a new procedure for treating osteoporotic
fractures, is designed to restore height to the bone
thus reducing deformity of the spine. Read
more...
By Courtney W. Brown, MD and Douglas C. Wong, MD
Update on artificial
discs (Research article)
May 5, 2000
The main objective of an artificial disc is to
replace a painful disc while maintaining the natural
anatomical structure of the spine. The procedure is
being developed as an alternative to lumbar spine fusion.
Read more...
By Stephen H. Hochschuler, MD
Intradiscal Electrothermal
Therapy (IDET) (Research article)
April 18, 2000
IDET is a new, minimally invasive outpatient
surgical procedure to treat patients with chronic low
back pain caused by tears or small herniations of their
lumbar discs. Read more...
By Ari Ben-Yishay, MD
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