NCT07287449
Not yet recruiting
Not Applicable
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dymicron EU GmbH
- Enrollment
- 164
- Primary Endpoint
- Composite Clinical Success
Overview
Brief Summary
A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female subject, age ≥
- •Diagnosis of radiculopathy or myeloradiculopathy 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:
- •Neck and/or arm pain (at least 30 mm on the 100 mm visual analogue scale \[VAS\] scale).
- •Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
- •Abnormal sensation including hyperesthesia or hypoesthesia; and/or
- •Abnormal reflexes.
- •Symptomatic at a single level from C3 to C
- •Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:
- •Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.
- •Degenerative spondylosis on CT or MRI.
Exclusion Criteria
- •Have an active systemic infection or infection at the operative site.
- •Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.
- •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.
- •Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.
- •Prior attempted or completed cervical spine surgery at any cervical level, except (1) a minimally invasive decompression that did not de-stabilize the segment upon flexion/extension or (2) a successful single-level anterior cervical fusion at non-index level (greater than 6 months prior to scheduled surgical treatment).
- •Have axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.
- •Have disc height less than 3 mm as measured from the center of the disc in a neutral position.
- •Evidence of symptomatic moderate to severe facet joint degeneration or disease where the investigator feels this is a major contributor to the subject's pain as diagnosed by injection and imaging.
- •Have osteoporosis or is an increased risk of osteoporosis/osteopenia defined as a T-score less than -1.5 (i.e., -1.6, -1.7, etc.).
- •The SCORE/MORES will be used to screen if a dual energy X-ray absorptiometry (DEXA) scan is required. If SCORE/MORES value ≥ 6, then a DEXA is required.
Outcomes
Primary Outcomes
Composite Clinical Success
Time Frame: 24 months
Absence of serious device-related adverse events, as adjudicated by the CEC.
Secondary Outcomes
- Clinically Significant Improvement(24 months)
Investigators
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