Clinical trial NCT04174534: ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spinal Disease
Lead sponsor: Spineart SA
Sponsor class: INDUSTRY
First posted: 2019-11-22
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ODI
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Montpellier
country: France
facility: Clinique St Jean
Study officials:
affiliation: Spineart SA
name: Dervilla Bermingham, MSc
role: STUDY_DIRECTOR
References: