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.

Recruiting N/A Interventional Study
Degenerative Disc Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 69
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
97 (estimated)
Sponsor
Highridge Medical · Industry
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About This Trial

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. 97 patients will receive the hybrid surgery and will be followed for a minimum of 2 years.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 (arm pain and /or a neurological deficit) with or without neck pain or myelopathy due to a two-level abnormality localized to th…
Contacts

Monica Barascout, BA

1-720-894-9016

monica.barascout@highridgemedical.com

CONTACT

Alex Pawlowski

1-720-894-9016

alex.pawlowski@highridgemedical.com

CONTACT