ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

NCT04174534 | Terminated

• 1 other identifier: P54_CLD004
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• ODI

  Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)

  24 months

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature patients with stenosis and Grade I degenerative spondylolisthesis, secondary to lumbar degenerative disc disease, indicated for treatment with Romeo 2 PAD at one level between L1 and S1.

You may qualify if:

• Surgical treatment of stenosis and Grade I degenerative spondylolisthesis, secondary to lumbar degenerative disc disease at one level between L1 and L5 in skeletally mature patients

You may not qualify if:

• Vertebral traumatic lesions including dislocation;
• Insufficient vertebral body bone quality;
• Severe osteoporosis;
• Bone tumor in the region of the implant;
• Spondylolysis;
• Lytic spondylolisthesis;
• Degenerative spondylolisthesis Grade II or more;
• Mental illness or inadequate patient activity;
• Infection;
• Vascular disorders or illness;
• Pregnancy

Sponsors & Collaborators

• Spineart SA: lead

Study Sites (3)

Hôpital de la Timone

Marseille, 13005, France

Location

CHU Gui de Chauliac

Montpellier, 34000, France

Location

Clinique St Jean

Montpellier, 34093, France

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Dervilla Bermingham, MSc

  Spineart SA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 22, 2019
• Study Start: October 11, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)