RecruitingNot Applicable

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.

United States97 participantsStarted 2024-09-01

Plain-language summary

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.

Who can participate

Age range22 Years – 69 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Composite Success

Timeframe: 24 months

Trial details

NCT IDNCT06485206

SponsorHighridge Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05

Contact for this trial

Monica Barascout, BA

1-720-894-9016 monica.barascout@highridgemedical.com

View on ClinicalTrials.gov More Degenerative Disc Disease trials