ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

Spinal Disease Clinical Trial

— ROMEO 2 PAD FR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04174534
• Other study ID #: P54_CLD004
• Status: Terminated
• Start date: October 11, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: March 2021
• Source: Spineart SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Locations

Country	Name	City	State
France	Hôpital de la Timone	Marseille
France	CHU Gui de Chauliac	Montpellier
France	Clinique St Jean	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Spineart SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI	Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)	24 months