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ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

NCT04174534 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2021-03-22

No results posted yet for this study

Summary

This study is designed as a post-marketing observational, controlled, prospective, non-inferiority study where the efficacy and safety of the Degenerative Disc Disease treatment by arthrodesis using PEEK(PolyEtherEtherKetone)-Titanium polyaxial interspinous posterior fusion device ROMEO®2 PAD will be compared to the gold standard treatment by instrumented circumferential arthrodesis.

The primary study aim is to evaluate functional improvement at 1 and 2 years after surgery. The fusion at 1 year and 2 years post-surgery, the short and long- term clinical and neurological success and patient related health status satisfaction will also be evaluated.

Conditions

  • Spinal Disease

Sponsors & Collaborators

  • Spineart SA

    lead INDUSTRY

Principal Investigators

  • Dervilla Bermingham, MSc · Spineart SA

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2020-11-11
Completion
2020-11-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04174534 on ClinicalTrials.gov