M54.12 M50.1
Conditions
Interventions
Group 1: The aim of this study is to collect clinical and radiographic information on patients suffering from intractable symptomatic cervical disc disease (SCDD) who require a 1- or 2-level reconstru
Sponsors
Dymicron EU GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male or female subject, age = 18 years. 2) Diagnosis of radiculopathy or myelopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following: a. Neck and/or arm pain (at least 30 mm on a 100 mm numerical rating scale [VAS]). b. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale. c. Abnormal sensation including hyperesthesia or hypoesthesia, and/or d. Abnormal reflexes e. Signs of myelopathy such as gait disturbance, fine motor function dysfunction, etc. 3) Symptomatic Cervical Disc Disease (SCDD) at one or two contiguous levels from C3 to C7. 4) Radiographically determined pathology (within 6 weeks of planned surgery date at the level to be treated correlating to primary symptoms including at least one of the following: a. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc. b. Degenerative symptomatic spondylosis on CT or MRI. c. Disc herniation on CT or MRI. 5) Neck Disability Index (NDI) score of =30 (out of 100). 6) Unresponsiveness to non-operative, conservative treatment (e.g., rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for: a. Approximately six weeks from the radiculopathy or myelopathy symptom onset, or b. Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment, or c. Sooner than six weeks for worsening symptoms of neurologic compromise. 7) Appropriate for treatment using anterior cervical surgical approach. 8) Reported to be medically cleared for surgery. 9) Reported to be physically and mentally able and willing to comply with the Protocol, including the ability to read and complete the required forms and willing and able to adhere to the scheduled follow-up visits. 10) Written informed consent provided by the subject.
Exclusion criteria
Exclusion criteria: 1) Have an active systemic infection or infection at the operative site. 2) Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C. 3) Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic “spontaneous” fusions. 4) Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury. 5) Prior attempted or completed cervical spine surgery at any cervical level, except (1) laminoforaminotomy (greater than 6 months prior to scheduled surgical treatment), which includes removal of disc material necessary to perform a nerve root decompression, with less than one-third facetectomy at any level, or (2) a successful single-level anterior cervical fusion (greater than 6 months prior to scheduled surgical treatment) not at the target level. 6) No bone growth stimulator uses within 30 days prior to surgery. 7) Have axial neck pain in the absence of other symptoms of radiculopathy or myelopathy justifying the need for surgical intervention. 8) Have disc height less than 3 mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body. 9) Have radiographic confirmation of severe facet joint disease or degeneration at target level(s). 10) Have osteoporosis or is at an increased risk of osteoporosis/osteopenia defined as a T-score less than -2.5 (i.e., -2.6, -2.7, etc.) on a previous dual energy X-ray absorptiometry (DEXA) scan within 6 months of surgery. Patients at risk for osteoporosis as determined by the Investigator are to undergo a DEXA scan (hip) as part of the study enrollment procedures. 11) Have diabetes mellitus requiring daily insulin management. 12) Have severe myelopathy to the extent that the patient is wheelchair bound. 13) Have Paget’s disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above (i.e., Exclusion #10). 14) Have active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years. 15) Have tumor as source of symptoms. 16) Have Symptomatic Cervical Degenerative Disc Disease (SDDD)or significant cervical spondylosis at more than two levels. 17) Have spondylolysis. 18) Have arachnoiditis. 19) At target level have marked cervical instability on resting (neutral) lateral or flexion-extension radiographs demonstrated by: a. Translation = 3.5 mm, and/or b. Greater than 11° angular difference to that of either adjacent level. 20) Have a known allergy to materials containing titanium, aluminum, vanadium, titanium carbide, cobalt, chrome, molybdenum, or tin. 21) Have segmental angulation of greater than 11° at treatment or adjacent levels. 22) Are currently pregnant or breastfeeding at time of enrollment or has plans to become pregnant within the next two years. 23) Have rheumatoid arthritis, lupus, or other autoimmune disease that affect the musculoskeletal system. 24) Have congenital bony and/or spinal cord abnormalities that affect spinal stability. 25) Reported to have diseases or conditions that would preclude accurate clinical evaluation (e.g., neuromuscular disorders), per Investigator’s discretion. 26) Have concomit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint used to assess safety and clinical performance of the Triadyme®-C cTDR is composite clinical success at 12 months defined by: 1. = 15-point improvement in NDI Score (out of 100) in subjects at 12 months compared with baseline. 2. Maintenance or improvement in neurological status (motor and sensory only) at 12 months compared to baseline. 3. No study failure due to secondary surgical interventions (revision, removal, re-operation, supplemental fixation) at the index level(s). 4. Absence of serious adverse device effects (SADE) as defined in section 9.4. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Neck pain 2) Left and right arm/shoulder pain 3) Health survey 4) Treatment satisfaction 5) Work status 6) Neurological evaluation 7) Myelopathy evaluation | — |
Countries
Germany, Spain
Contacts
Public ContactBjörn H. Weller
Consultant
Outcome results
None listed