Spinal DiseaseROMEO 2 PAD FRNCT04174534
ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP
An observational study of Spinal Disease, run by Spineart SA at 3 sites in France.
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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Spinal Disease
- How many people
- 3 participants
- Where
- 3 sitesFrance
- Study dates
- 11 Oct 2019to 11 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Vertebral traumatic lesions including dislocation;
- Insufficient vertebral body bone quality;
- Severe osteoporosis;
- Bone tumor in the region of the implant;
- Spondylolysis;
- Lytic spondylolisthesis;
Show all 11Show fewer
- Degenerative spondylolisthesis Grade II or more;
- Mental illness or inadequate patient activity;
- Infection;
- Vascular disorders or illness;
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital de la Timone
Marseille, 13005
CHU Gui de Chauliac
Montpellier, 34000
Clinique St Jean
Montpellier, 34093
About this study
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
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.
Read the 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.
- Conditions
- Spinal Disease
- Medical subject headings
- Spinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI
Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start11 Oct 2019
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Why it stopped: Weak enrollment rate and sanitary situation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spineart SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dervilla Bermingham, MSc, Study director, Spineart SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174534
- Sponsor's protocol ID
- P54_CLD004
- Acronym
- ROMEO 2 PAD FR
- Status last verified
- Mar 2021
- First submitted
- 21 Nov 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04174534
- Acronym / sponsor ID
- ROMEO 2 PAD FR / P54_CLD004
- Conditions
- Spinal Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Weak enrollment rate and sanitary situation
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Spineart SAIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- Vertebral traumatic lesions including dislocation;
- Insufficient vertebral body bone quality;
- Severe osteoporosis;
- Bone tumor in the region of the implant;
- Spondylolysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ODI
Time frame: 24 months
Absolute change in ODI at 12 and 24 months post-operative compared to baseline (pre-operative status)
Results and safety
The study was stopped early (reason given: Weak enrollment rate and sanitary situation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dervilla Bermingham, MSc study director
Spineart SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease, run by Spineart SA at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Weak enrollment rate and sanitary situation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.