Clinical trial NCT02967575: Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)
Official title: Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR): Evaluation of Clinical and Radiographic Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intervertebral Disc Disorder Cervical
Keywords: cervical total disc replacement (cTDR)
Lead sponsor: Dymicron EU GmbH
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic of selected spine centers

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 1- or 2-level cTDR surgery between C3 and C7
2. Age ≥ 18 years
3. Skeletally mature patient
4. Patient suffers from intractable symptomatic cervical disc disease (SCDD) with neck or arm (radicular) pain and/or a functional/neurological deficit
5. At least one of the following conditions must be present and confirmed by radiographic (CT, MRI, x-ray, etc.) studies: herniated nucleus pulposus, spondylosis (indicated by the presence of osteophytes), or loss of disc height.
6. At least six weeks of non-operative treatment for SCDD has been tried and failed prior to implantation
7. Psychosocially, mentally, and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.
8. Patient signed Informed Consent

Exclusion Criteria:

1. Active systemic infection or infection localized to the site of implantation
2. Allergy or sensitivity to the implant materials
3. Osteoporosis, defined as a Dual-energy X-ray Absorptiometry (DXA) bone mineral density T-score equal to or less than -2.5
4. Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments)
5. Severe spondylosis characterized by bridging osteophytes or an absence of motion (less than 2 degrees)
6. Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g. ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma)
7. Significant kyphotic deformity or significant reversal of lordosis
8. Previous cervical spinal surgery, other than discectomy at the levels to be operated on
9. Use of any spinal implant other than Triadyme-C
10. Adiposity, severe obesity (BMI \> 40 kg/m2)
11. Patient who takes immunosuppressive or long-term steroid use
12. Fever
13. Systemic or metabolic illnesses (i.e. disease of bone-metabolism, insulin-dependent diabetes ...)
14. Patient who is suffering from rheumatoid or other inflammatory joint disease
15. Patient with any known active malignancy within the last 2 years
16. Any medical or surgical condition that could preclude the potential success of the implantation
17. Psychosocial issues; lack of co-operation by the patient, drug abuse or alcoholism
18. Unwillingness or inability of the patient to follow the instructions for postoperative treatment or with the follow-up evaluation schedule
19. Female patient who is pregnant or plans to become pregnant during the course of the study
20. Prisoner

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Visual Analogue Scale (VAS) on neck pain
timeFrame: 2 years postoperative
measure: Visual Analogue Scale (VAS) on arm pain
timeFrame: 2 years postoperative
measure: Rate of device failure
timeFrame: 2 years postoperative
measure: Rate of subsequent surgical interventions
timeFrame: 2 years postoperative
measure: Range of motion at index level
timeFrame: 2 years postoperative
measure: Rate of subsequent surgical interventions at symptomatic adjacent levels
timeFrame: 2 years postoperative
Other outcomes:
measure: Adverse Events
timeFrame: 2 years postoperative
measure: Change in postoperative disc height at index level
timeFrame: 2 years postoperative
measure: Heterotopic ossification (HO) at index level
timeFrame: 2 years postoperative
measure: Neurological status
timeFrame: 2 years postoperative
measure: Patient's work status
timeFrame: 2 years postoperative
measure: Patient's satisfaction
timeFrame: 2 years postoperative
Locations:
city: Kummersbruck
country: Germany
facility: Orth.med
state: Bayern
city: Rostock
country: Germany
facility: Klinikum der Universität Rostock Abteilung für Neurochirurgie
state: Mecklenburg Vorpommern
city: Ganderkesee
country: Germany
facility: STENUM Ortho GmbH
state: Niedersachsen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Klinik für Unfall- und Wiederherstellungschirurgie
Study officials:
affiliation: Stenum Ortho GmbH
name: Jan Spiller, MD
role: PRINCIPAL_INVESTIGATOR
References: