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Tests treatment safety and results for Degenerative Disc Disease
Official title Evaluation of Safety and Effectiveness of Primary Hybrid Construct of Mobi-C and ACDF in the Treatment of Two-level Symptomatic Degenerative Disc Disease in the Cervical Spine.
ClinicalTrials.gov ID: NCT06485206
What this study is testing
- What it's testing
- The study is a prospective, multi-center cohort study of patients with two-level DDD implanted with CDA adjacent to ACDF (hybrid construct). The overall success of the hybrid procedure will be compared to 2-level ACDF historical controls from the Mobi-C IDE trial.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 69
You may be able to join if
- 1\. Age 22 - 69 years. 2. Have symptoms of cervical degenerative disc disease (DDD) at two levels from C3 to T1 defined as intractable radiculopathy...
- Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
- Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment. 6\...
You likely can't join if
- 1\. Symptomatic DDD or significant cervical spondylosis at more than two levels 2. Reported to have an active systemic infection or infection at the...
- Translation greater than 3.5mm, and/or
- Greater than 11° angular difference to that of either adjacent level 10. Segmental angulation of greater than 11° at treatment or adjacent levels 11...
- For patients less than 50 years of age, the Simple Calculated Osteoporosis Risk Estimation (SCORE) questionnaire will be used to screen patients for...
- Patients will be excluded if the DEXA scan results indicate a T-SCORE worse than -1.0 13. Any disease, condition or surgery which might impair...
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Southfield, Michigan, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Southfield, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.