<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967575</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 16/01</org_study_id>
    <nct_id>NCT02967575</nct_id>
  </id_info>
  <brief_title>Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR)</brief_title>
  <official_title>Triadyme-C, a Polycrystalline Diamond Compact Cervical Disc Replacement (cTDR): Evaluation of Clinical and Radiographic Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dymicron EU GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dymicron EU GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic&#xD;
      outcome information on patients suffering from intractable symptomatic cervical disc disease&#xD;
      requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the&#xD;
      Triadyme-C polycrystalline diamond compact cervical disc replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately fifty percent of the population has evidence of degenerative changes in their&#xD;
      cervical spine by the age of fifty. As part of the aging process, the intervertebral discs&#xD;
      wear out. They lose their flexibility and elasticity and begin to collapse or even herniate.&#xD;
      This process may result in a pathological condition called cervical Degenerative Disc&#xD;
      Diseases (cDDD). cDDD can either be asymptomatic or symptomatic, showing different symptoms&#xD;
      such as neck, shoulder, head, arm or leg pain, possibly associated with numbness, tingling or&#xD;
      weakness in the upper extremity. In most cases symptomatic cDDD is initially treated&#xD;
      conservatively with rest, immobilization, physical therapy, chiropractic manipulation and&#xD;
      pain medication. For those cases not responding to conservative therapy, anterior cervical&#xD;
      discectomy and fusion (ACDF) is a standard technique. The primary purpose of ACDF is to&#xD;
      excise any disc material (discectomy), which compresses the spinal nerve or cord causing&#xD;
      pain, sensory disturbance or weakness at the affected level, followed by interbody fusion of&#xD;
      the adjacent vertebrae using grafts or intersomatic devices to compensate the instability and&#xD;
      the loss of disc height resulting from discectomy. Despite the success of this common&#xD;
      procedure, some disadvantages are to be mentioned including donor site morbidity when&#xD;
      autografts are used, graft or device subsidence or pseudarthrosis of the segment to be fused.&#xD;
      Besides this, physiological motion of successfully fused segments is no longer possible. This&#xD;
      alters the loading and kinematics of adjacent spine segments which is believed by some&#xD;
      authors to lead to adjacent segment overload as reported by several clinical and&#xD;
      biomechanical studies. To address the disadvantages of ACDF, cervical total disc replacement&#xD;
      (cTDR) has been developed in the 1990s, with the aim to carry the load and restore the normal&#xD;
      disc height while preserving almost physiological segmental motion.&#xD;
&#xD;
      Today, several different cTRD designs are on the market, some of them with mid- to long-term&#xD;
      results. A number of randomized controlled trials indicate clinical equivalence or even&#xD;
      superiority of cTDR in some aspects compared to ACDF.&#xD;
&#xD;
      The Dymicron Triadyme-C cTDR is a two-piece articulating artificial disc prosthesis. Its&#xD;
      patented tri-lobe articulation mechanism consists of three spherical lobes mating to three&#xD;
      non-congruent, spherical pockets. The motion of these three lobes within their associated&#xD;
      pockets emulates and controls natural motion of the cervical spine motion segment in all&#xD;
      degrees of freedom.Triadyme-C is a self-centering device. This is achieved by the implant&#xD;
      growing in height as it moves away from its center. The further away from center, the tighter&#xD;
      the ligaments will be stretched. Each half of the Triadyme-C is a sintered monobloc,&#xD;
      consisting of a polycrystalline diamond (PCD) bearing surface with a base of&#xD;
      titanium-titanium carbide (Ti-TiC) composite. PCD is a sintered material composed of fused&#xD;
      diamond crystals (typically more than 90%) and a small amount of catalyst sintering metal.&#xD;
      The polycrystalline structure of diamond, together with the small amount of residual metal&#xD;
      alloy, contributes significantly to the extraordinary toughness and abrasion-resistance of&#xD;
      the material. PCD retains many of the phenomenal properties of natural diamond, including&#xD;
      hardness, but in an isotropic form that is far more resistant to fracture.&#xD;
&#xD;
      This Post Market Clinical Follow-up (PMCF) is conducted to collect clinical and radiographic&#xD;
      outcome information on patients suffering from intractable symptomatic cervical disc disease&#xD;
      requiring 1- or 2-level reconstruction of the disc from C3-C7, after being treated with the&#xD;
      Triadyme-C polycrystalline diamond compact cervical disc replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Clinical outcome is measured by the Neck Disability Index (NDI) as published by Vernon et. al.. The primary endpoint of the study will be the mean total NDI at the 2 year postoperative assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) on neck pain</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The Visual Analogue Scale (VAS) represents the subject's intensity of neck pain during the last week measured on a line of 10 cm length, stretching from 'no pain (0 cm) to 'pain as bad as it could be' (10 cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS) on arm pain</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The VAS represents the subject's intensity of pain experienced in the pain-dominant arm during the last week measured on a line of 10 cm length, stretching from 'no pain (0 cm) to 'pain as bad as it could be' (10 cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of device failure</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Failure rate is based on the number of subjects whose radiographs, MRIs and/or CTs showed one or more device failures during the 2 year follow-up period after implantation divided by the total number of patients with 2 year radiographs or earlier failures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of subsequent surgical interventions</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The following subsequent surgical intervention rates at index level are secondary study endpoints&#xD;
removal&#xD;
revision&#xD;
reoperation&#xD;
supplemental fixation&#xD;
Each subsequent surgical intervention rate is based on the number of subjects who showed one or more surgical interventions at index level per category during the 2 year follow-up period after implantation divided by the total number of patients with 2 year results or earlier subsequent surgical interventions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion at index level</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Range of motion (ROM) at index level means the degree of flexion/extension motion in the replaced segment. It is measured along the endplates according to the technique of Cobb in degrees in the sagittal plane on active lateral flexion and extension radiographs. ROM is defined as the difference of endplate alignment (Cobb angle) in maximum active flexion and maximum active extension per follow-up examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of subsequent surgical interventions at symptomatic adjacent levels</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The rate of subsequent surgical interventions at symptomatic adjacent levels is based on the number of subjects who underwent subsequent surgery to treat progressive adjacent segment disease during the 2 year follow-up period after implantation divided by the total number of patients with 2 year results or earlier adjacent subsequent surgical interventions.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Reporting of AE (adverse device effects (ADE) / procedure related AEs / other AEs) and by seriousness (serious AE (SAE) / non-serious AE) and intensity (mild / moderate / severe) is performed by the Principal Investigator based upon all reported adverse events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in postoperative disc height at index level</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>Postoperative disc height at index level means the average disc height at the instrumented level. Therefore the anterior and posterior height will be measured from neutral lateral radiographs according to the radiographic protocol. Average height is calculated as the average of the corresponding anterior and posterior heights. Correction of magnification is performed for all distances measured according to the radiographic protocol.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heterotopic ossification (HO) at index level</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>HO is evaluated according to McAfee et al.</description>
  </other_outcome>
  <other_outcome>
    <measure>Neurological status</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The patient's neurological function is recorded preoperatively and at all postoperative follow-ups. The assessment includes motor, sensory and reflex evaluations by dermatome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient's work status</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>The patient's work status is recorded by the patient preoperatively and at all postoperative follow-ups. It is documented by the following categories:&#xD;
working&#xD;
not working due to neck disability&#xD;
not working for reasons other than neck disability</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient's satisfaction</measure>
    <time_frame>2 years postoperative</time_frame>
    <description>A VAS represents the patient's satisfaction with the outcome of the cTDR during the last week measured on a line of 10 cm length, stretching from 'extremely satisfied' (0 cm) to 'extremely dissatisfied' (10 cm).</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Intervertebral Disc Disorder Cervical</condition>
  <arm_group>
    <arm_group_label>1- or 2-level cTDR</arm_group_label>
    <description>patients suffering from intractable symptomatic cervical disc disease (SCDD) requiring 1- or 2-level reconstruction of the disc from C3-C7</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cTDR</intervention_name>
    <description>The surgical procedure for the Triadyme-C total disc replacement corresponds to the standard surgical technique for cTDR:&#xD;
Implantation through a standard anterior cervical approach&#xD;
Midline identification&#xD;
Routine discectomy with endplate preparation and decompression&#xD;
Implant sizing and trial implantation&#xD;
Keel preparation&#xD;
Implant preparation and loading of the appropriate Triadyme-C implant&#xD;
Triadyme-C insertion, positioned as close to the midline as possible</description>
    <arm_group_label>1- or 2-level cTDR</arm_group_label>
    <other_name>cervical Total Disc Replacement</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic of selected spine centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 1- or 2-level cTDR surgery between C3 and C7&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. Skeletally mature patient&#xD;
&#xD;
          4. Patient suffers from intractable symptomatic cervical disc disease (SCDD) with neck or&#xD;
             arm (radicular) pain and/or a functional/neurological deficit&#xD;
&#xD;
          5. At least one of the following conditions must be present and confirmed by radiographic&#xD;
             (CT, MRI, x-ray, etc.) studies: herniated nucleus pulposus, spondylosis (indicated by&#xD;
             the presence of osteophytes), or loss of disc height.&#xD;
&#xD;
          6. At least six weeks of non-operative treatment for SCDD has been tried and failed prior&#xD;
             to implantation&#xD;
&#xD;
          7. Psychosocially, mentally, and physically able to fully comply with the clinical&#xD;
             protocol and willing to adhere to follow-up schedule and requirements.&#xD;
&#xD;
          8. Patient signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active systemic infection or infection localized to the site of implantation&#xD;
&#xD;
          2. Allergy or sensitivity to the implant materials&#xD;
&#xD;
          3. Osteoporosis, defined as a Dual-energy X-ray Absorptiometry (DXA) bone mineral density&#xD;
             T-score equal to or less than -2.5&#xD;
&#xD;
          4. Marked cervical instability on radiographs (e.g., radiographic signs of subluxation&#xD;
             greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than&#xD;
             adjacent segments)&#xD;
&#xD;
          5. Severe spondylosis characterized by bridging osteophytes or an absence of motion (less&#xD;
             than 2 degrees)&#xD;
&#xD;
          6. Significant cervical anatomical deformity or compromised vertebral bodies at the index&#xD;
             level (e.g. ankylosing spondylitis, rheumatoid arthritis, or compromise due to current&#xD;
             or past trauma)&#xD;
&#xD;
          7. Significant kyphotic deformity or significant reversal of lordosis&#xD;
&#xD;
          8. Previous cervical spinal surgery, other than discectomy at the levels to be operated&#xD;
             on&#xD;
&#xD;
          9. Use of any spinal implant other than Triadyme-C&#xD;
&#xD;
         10. Adiposity, severe obesity (BMI &gt; 40 kg/m2)&#xD;
&#xD;
         11. Patient who takes immunosuppressive or long-term steroid use&#xD;
&#xD;
         12. Fever&#xD;
&#xD;
         13. Systemic or metabolic illnesses (i.e. disease of bone-metabolism, insulin-dependent&#xD;
             diabetes ...)&#xD;
&#xD;
         14. Patient who is suffering from rheumatoid or other inflammatory joint disease&#xD;
&#xD;
         15. Patient with any known active malignancy within the last 2 years&#xD;
&#xD;
         16. Any medical or surgical condition that could preclude the potential success of the&#xD;
             implantation&#xD;
&#xD;
         17. Psychosocial issues; lack of co-operation by the patient, drug abuse or alcoholism&#xD;
&#xD;
         18. Unwillingness or inability of the patient to follow the instructions for postoperative&#xD;
             treatment or with the follow-up evaluation schedule&#xD;
&#xD;
         19. Female patient who is pregnant or plans to become pregnant during the course of the&#xD;
             study&#xD;
&#xD;
         20. Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Spiller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stenum Ortho GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orth.med</name>
      <address>
        <city>Kummersbruck</city>
        <state>Bayern</state>
        <zip>92245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Rostock Abteilung für Neurochirurgie</name>
      <address>
        <city>Rostock</city>
        <state>Mecklenburg Vorpommern</state>
        <zip>18055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>STENUM Ortho GmbH</name>
      <address>
        <city>Ganderkesee</city>
        <state>Niedersachsen</state>
        <zip>27777</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin Klinik für Unfall- und Wiederherstellungschirurgie</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cervical total disc replacement (cTDR)</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967575
org study id: CIP 16/01
nct id: NCT02967575
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Neck Disability Index (NDI)
time frame: 2 years postoperative
description: Clinical outcome is measured by the Neck Disability Index (NDI) as published by Vernon et. al.. The primary endpoint of the study will be the mean total NDI at the 2 year postoperative assessment.
measure: Visual Analogue Scale (VAS) on neck pain
time frame: 2 years postoperative
description: The Visual Analogue Scale (VAS) represents the subject's intensity of neck pain during the last week measured on a line of 10 cm length, stretching from 'no pain (0 cm) to 'pain as bad as it could be' (10 cm).
measure: Visual Analogue Scale (VAS) on arm pain
time frame: 2 years postoperative
description: The VAS represents the subject's intensity of pain experienced in the pain-dominant arm during the last week measured on a line of 10 cm length, stretching from 'no pain (0 cm) to 'pain as bad as it could be' (10 cm).
measure: Rate of device failure
time frame: 2 years postoperative
description: Failure rate is based on the number of subjects whose radiographs, MRIs and/or CTs showed one or more device failures during the 2 year follow-up period after implantation divided by the total number of patients with 2 year radiographs or earlier failures.
measure: Rate of subsequent surgical interventions
time frame: 2 years postoperative
description: The following subsequent surgical intervention rates at index level are secondary study endpoints
removal
revision
reoperation
supplemental fixation
Each subsequent surgical intervention rate is based on the number of subjects who showed one or more surgical interventions at index level per category during the 2 year follow-up period after implantation divided by the total number of patients with 2 year results or earlier subsequent surgical interventions.
measure: Range of motion at index level
time frame: 2 years postoperative
description: Range of motion (ROM) at index level means the degree of flexion/extension motion in the replaced segment. It is measured along the endplates according to the technique of Cobb in degrees in the sagittal plane on active lateral flexion and extension radiographs. ROM is defined as the difference of endplate alignment (Cobb angle) in maximum active flexion and maximum active extension per follow-up examination.
measure: Rate of subsequent surgical interventions at symptomatic adjacent levels
time frame: 2 years postoperative
description: The rate of subsequent surgical interventions at symptomatic adjacent levels is based on the number of subjects who underwent subsequent surgery to treat progressive adjacent segment disease during the 2 year follow-up period after implantation divided by the total number of patients with 2 year results or earlier adjacent subsequent surgical interventions.
measure: Adverse Events
time frame: 2 years postoperative
description: Reporting of AE (adverse device effects (ADE) / procedure related AEs / other AEs) and by seriousness (serious AE (SAE) / non-serious AE) and intensity (mild / moderate / severe) is performed by the Principal Investigator based upon all reported adverse events.
measure: Change in postoperative disc height at index level
time frame: 2 years postoperative
description: Postoperative disc height at index level means the average disc height at the instrumented level. Therefore the anterior and posterior height will be measured from neutral lateral radiographs according to the radiographic protocol. Average height is calculated as the average of the corresponding anterior and posterior heights. Correction of magnification is performed for all distances measured according to the radiographic protocol.
measure: Heterotopic ossification (HO) at index level
time frame: 2 years postoperative
description: HO is evaluated according to McAfee et al.
measure: Neurological status
time frame: 2 years postoperative
description: The patient's neurological function is recorded preoperatively and at all postoperative follow-ups. The assessment includes motor, sensory and reflex evaluations by dermatome.
measure: Patient's work status
time frame: 2 years postoperative
description: The patient's work status is recorded by the patient preoperatively and at all postoperative follow-ups. It is documented by the following categories:
working
not working due to neck disability
not working for reasons other than neck disability
measure: Patient's satisfaction
time frame: 2 years postoperative
description: A VAS represents the patient's satisfaction with the outcome of the cTDR during the last week measured on a line of 10 cm length, stretching from 'extremely satisfied' (0 cm) to 'extremely dissatisfied' (10 cm).
arm group label: 1- or 2-level cTDR
description: patients suffering from intractable symptomatic cervical disc disease (SCDD) requiring 1- or 2-level reconstruction of the disc from C3-C7
intervention type: Device
intervention name: cTDR
description: The surgical procedure for the Triadyme-C total disc replacement corresponds to the standard surgical technique for cTDR:
Implantation through a standard anterior cervical approach
Midline identification
Routine discectomy with endplate preparation and decompression
Implant sizing and trial implantation
Keel preparation
Implant preparation and loading of the appropriate Triadyme-C implant
Triadyme-C insertion, positioned as close to the midline as possible
arm group label: 1- or 2-level cTDR
other name: cervical Total Disc Replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jan Spiller, MD
role: Principal Investigator
affiliation: Stenum Ortho GmbH
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No