ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP (ROMEO 2 PAD FR)

DEGENERATIVE DISC DISEASE TREATED BY DECOMPRESSION AND ARTHRODESIS USING A PEEK-TITANIUM POLYAXIAL INTERSPINOUS POSTERIOR FUSION DEVICE: ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Disease

Detailed Description

Lumbar spine fusion is the gold standard technique for the treatment of low-back pain due to various spinal pathologies mostly related to degenerative conditions. Pedicle-screws constructs are widely used to achieve a strong fixation but may be associated with potential complications.

ROMEO® 2 PAD is composed of two polyaxial titanium teethed plates to adapt to anatomical variations, one step locking mechanism and a radiolucent polymer cylinder.

The ROMEO®2 PAD is a posterior non pedicle supplemental fixation device intended for use in combination with an inter-somatic device, to achieve fusion at single or multilevel in the lumbar spine (L1-S1 inclusive). A range of six heights (from 8 to 18mm) are designed to fit anatomical variations. It is intended for plate fixation to the spinous process for the purpose of achieving spinal fixation.

The main objective of the study is the evaluation of functional improvement as measured by changes in Oswestry Disability Index (ODI) at 12 and 24 months after surgery, respectively.

The secondary objectives are:

• Evaluation of fusion rate at 12 and 24 months after surgery, respectively, based on CT scans.
• Evaluation of mobility at the treated level at 12 and 24 months after surgery, respectively, based on ROM (Range of motion) assessed using dynamic lumbar flexion-extension radiography.
• Evaluation of functional capacities post-surgery, as measured by ODI. Comparison between preoperative status and controls at 6 weeks, 6 months after surgery, respectively.
• Evaluation of Health-related Quality of Life (HR-QOL) improvement and patient satisfaction, as measured by SF-36 (Short Form 36) scores, the physical (PCS) and mental (MCS) components; comparison between preoperative status and controls at 6 weeks, 6, at 12 and 24 months after surgery, respectively.
• Evaluation of low back and legs pain as measured by Visual Analogue Scale (VAS) (changes in VAS scores): comparison between preoperative status and controls at 6 weeks, 6, 12 and 24 months after surgery, respectively.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Hôpital de la Timone
  • Montpellier, France, 34000
    • CHU Gui de Chauliac
  • Montpellier, France, 34093
    • Clinique St Jean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ODI	Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)	24 months

Collaborators and Investigators

• Sponsor: Spineart SA
• Investigators: Study Director: Dervilla Bermingham, MSc, Spineart SA

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): November 11, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: P54_CLD004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No