Intervertebral Disc Disorder Cervical Clinical Trial
Official title:
Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR): Evaluation of Clinical and Radiographic Outcome
This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic outcome information on patients suffering from intractable symptomatic cervical disc disease requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the Triadyme-C polycrystalline diamond compact cervical disc replacement.
Approximately fifty percent of the population has evidence of degenerative changes in their
cervical spine by the age of fifty. As part of the aging process, the intervertebral discs
wear out. They lose their flexibility and elasticity and begin to collapse or even herniate.
This process may result in a pathological condition called cervical Degenerative Disc
Diseases (cDDD). cDDD can either be asymptomatic or symptomatic, showing different symptoms
such as neck, shoulder, head, arm or leg pain, possibly associated with numbness, tingling or
weakness in the upper extremity. In most cases symptomatic cDDD is initially treated
conservatively with rest, immobilization, physical therapy, chiropractic manipulation and
pain medication. For those cases not responding to conservative therapy, anterior cervical
discectomy and fusion (ACDF) is a standard technique. The primary purpose of ACDF is to
excise any disc material (discectomy), which compresses the spinal nerve or cord causing
pain, sensory disturbance or weakness at the affected level, followed by interbody fusion of
the adjacent vertebrae using grafts or intersomatic devices to compensate the instability and
the loss of disc height resulting from discectomy. Despite the success of this common
procedure, some disadvantages are to be mentioned including donor site morbidity when
autografts are used, graft or device subsidence or pseudarthrosis of the segment to be fused.
Besides this, physiological motion of successfully fused segments is no longer possible. This
alters the loading and kinematics of adjacent spine segments which is believed by some
authors to lead to adjacent segment overload as reported by several clinical and
biomechanical studies. To address the disadvantages of ACDF, cervical total disc replacement
(cTDR) has been developed in the 1990s, with the aim to carry the load and restore the normal
disc height while preserving almost physiological segmental motion.
Today, several different cTRD designs are on the market, some of them with mid- to long-term
results. A number of randomized controlled trials indicate clinical equivalence or even
superiority of cTDR in some aspects compared to ACDF.
The Dymicron Triadyme-C cTDR is a two-piece articulating artificial disc prosthesis. Its
patented tri-lobe articulation mechanism consists of three spherical lobes mating to three
non-congruent, spherical pockets. The motion of these three lobes within their associated
pockets emulates and controls natural motion of the cervical spine motion segment in all
degrees of freedom.Triadyme-C is a self-centering device. This is achieved by the implant
growing in height as it moves away from its center. The further away from center, the tighter
the ligaments will be stretched. Each half of the Triadyme-C is a sintered monobloc,
consisting of a polycrystalline diamond (PCD) bearing surface with a base of
titanium-titanium carbide (Ti-TiC) composite. PCD is a sintered material composed of fused
diamond crystals (typically more than 90%) and a small amount of catalyst sintering metal.
The polycrystalline structure of diamond, together with the small amount of residual metal
alloy, contributes significantly to the extraordinary toughness and abrasion-resistance of
the material. PCD retains many of the phenomenal properties of natural diamond, including
hardness, but in an isotropic form that is far more resistant to fracture.
This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic
outcome information on patients suffering from intractable symptomatic cervical disc disease
requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the
Triadyme-C polycrystalline diamond compact cervical disc replacement.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04883411 -
CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study
|
N/A |