Long-term results after back surgery for deformity using the Romeo®2 System

ISRCTN	ISRCTN13615218
DOI	https://doi.org/10.1186/ISRCTN13615218
Internal reference	P50_CLD002
Sponsor	Spineart (Switzerland)
Funder	Spineart SA

Submission date: 14/01/2026
Registration date: 15/01/2026
Last edited: 27/01/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims:
Posterior screw fixation is a well-known surgical method used to stabilize the middle and lower parts of the spine when there are problems like spinal deformities. The Romeo® 2 and Romeo® 2 MIS systems are recognized and widely used technologies for this purpose. The aim of the study is to gather and review real-world evidence over time to confirm that these systems are effective, safe and provide clinical benefits for treating spinal deformities.

Who can participate?
This study involves only the collection and analysis of existing data. We will include data from patients in the participating centers who previously underwent surgery using the ROMEO®2 or ROMEO®2 MIS system to treat spinal deformity, provided that images and questionnaire results are available from at least 22 months after surgery. Data will only be used if the patient has not formally objected to its use for research purposes.

What does the study involve?
All the data will be collected per the sites’ standard of care and based on their availability in the medical records as real-world evidence. This includes preoperative data, surgical details, and immediate to long-term postoperative follow-up information.

What are the possible benefits and risks of participating?
As this is a retrospective data collection study, there are no direct benefits or risks for participants. The study uses only existing data, and no additional procedures or interventions will be performed.

Where is the study run from?
Spineart SA (Switzerland)

When is the study starting and how long is it expected to run for?
March 2026 to August 2026

Who is funding the study?
Spineart SA (Switzerland)

Who is the main contact?
clinic@spineart.com

Contact information

Mrs Dervilla Bermingham
Public, Scientific

Spineart SA - Clinical Affairs
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland

Phone	+41 (0)225611200
Email	clinic@spineart.com

Prof Tanguy Vendeuvre
Principal investigator

CHU Poitiers
2 Rue de la Milétrie
Poitiers
86000
France

Phone	+41 (0)225611200
Email	clinic@spineart.com

Study information

Primary study design	Observational
Observational study design	Case series
Scientific title	Evaluation of long-term clinical and radiographic outcomes after spinal surgery using the Romeo®2 / Romeo®2 MIS posterior fixation system to treat spinal deformities
Study acronym	Romeo®2 Deformity
Study objectives	To confirm over time the clinical benefit, the performance and the safety of the Romeo®2 / Romeo®2 MIS system.
Ethics approval(s)	Ethics approval not required
Health condition(s) or problem(s) studied	Chronic instabilities or deformities of the thoracic, lumbar and sacral spine due to degenerative disc disease (painful degeneration of the disc), spondylolisthesis, spinal stenosis (up to 4 levels), tumor (1 level), trauma (up to 2 levels), deformities (i.e. scoliosis, kyphosis, or lordosis) indicated up to 15 levels
Intervention	Current methodology as of 27/01/2026: The study is observational, only a retrospective collection of existing data is planned. As the primary function, the ROMEO® 2 System is intended to provide immobilization and stabilization of spinal segments for the treatment of thoracolumbar spine instabilities due to spinal deformities. The study aims to confirm over time the clinical benefit of the ROMEO®2 / ROMEO®2 MIS system by assessing patient-reported outcomes when available, including pain using the Visual Analog Scale (VAS) for back and leg, functional capacity using the Oswestry Disability Index (ODI), and health-related quality of life using the SRS-22r questionnaire. It also seeks to confirm the system’s performance by evaluating the deformity correction on EOS or full-spine X-rays (when images are available) and the posterior fusion status at last follow up visit. The study also serves to confirm the long-term safety of ROMEO®2 / ROMEO®2 MIS system. Previous methodology: The study is observational, only a retrospective collection of existing data is planned. As the primary function, the ROMEO® 2 System is intended to provide immobilization and stabilization of spinal segments for the treatment of thoracolumbar spine instabilities due to spinal deformities. The study aims to confirm over time the clinical benefit of the ROMEO®2 / ROMEO®2 MIS system by assessing patient-reported outcomes when available, including pain using the Visual Analog Scale (VAS) for back and leg, functional capacity using the Oswestry Disability Index (ODI), and health-related quality of life using the SRS-22r questionnaire. It also seeks to confirm the system’s performance by evaluating deformity correction on EOS or full-spine X-rays when images are available, and to confirm its long-term safety.
Intervention type	Device
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Romeo®2 / Romeo®2 MIS system
Primary outcome measure(s)	Pain (back and leg) measured using visual analogue scale (VAS) at the last postoperative follow-up visit and at each postoperative follow-up visit versus baseline (if data available) Functional capacity measured using Oswestry Disability Index (ODI) at the last postoperative follow-up visit and at each postoperative follow-up visit versus baseline (if data available) Health-related quality of life measured using SRS-22r at the last postoperative follow-up visit and at each postoperative follow-up visit versus baseline (if data available) Updated 27/01/2026, previous primary outcomes: 1. Pain (back and leg) measured using visual analogue scale (VAS) at each postoperative follow-up visit versus baseline (if data available) 2. Functional capacity measured using Oswestry Disability Index (ODI) at each postoperative follow-up visit versus baseline (if data available) 3. Health-related quality of life measured using SRS-22r at each postoperative follow-up visit versus baseline (if data available)
Key secondary outcome measure(s)	Correction and maintenance of the deformity measured using spinopelvic parameters in the coronal plane (Cobb angle, coronal balance (C7 plumb line), lumbar spine modifier) at each postoperative follow-up visit versus baseline Correction and maintenance of the deformity measured using spinopelvic parameters in the sagittal plane (lumbar lordosis, thoracic kyphosis T1-T12 & T5-T12 angles, pelvic incidence, sacral slope, pelvic tilt, sagittal vertebral axis, C7 slope, odontoid to hip axis angle, PI-LL mismatch) at each postoperative follow-up visit versus baseline Posterior fusion status measured using visual assessment at last postoperative follow-up visit Fusion status (in case of interbody device implantation) measured using Brantigan-Steffee-Fraser (BSF) classification at last postoperative follow-up visit Safety measured using reported adverse device effects (ADEs), serious adverse device effects (SADEs), Unanticipated Serious Adverse Device Effects (USADEs) including all surgical revisions and reoperations at all the postoperative follow-up visits and during surgery (if data available) Safety measured using the rate of device deficiencies that might have led to a SADE at all the postoperative follow-up visits (if data available) Updated 27/01/2026, previous secondary outcomes: 1. The correction of the deformity and its maintenance measured using spinopelvic parameters in the coronal plane (Cobb angle, coronal balance (C7 plumb line), lumbar spine modifier) at each postoperative follow-up visit versus baseline 2. The correction of the deformity and its maintenance measured using spinopelvic parameters in the sagittal plane (lumbar lordosis, thoracic kyphosis T1-T12 & T5-T12 angles, pelvic incidence, sacral slope, pelvic tilt, sagittal vertebral axis, C7 slope, odontoid to hip axis angle, PI-LL mismatch) at each postoperative follow-up visit versus baseline 3. The fusion status (in case of interbody device implantation) measured using Brantigan-Steffee-Fraser (BSF) classification at last postoperative follow-up visit 4. Safety measured using reported adverse device effects (ADEs), serious adverse device effects (SADEs), Unanticipated Serious Adverse Device Effects (USADEs) including all surgical revisions and reoperations at all the postoperative follow-up visits and during surgery (if data available) 5. Safety measured using the rate of device deficiencies that might have led to a SADE at all the postoperative follow-up visits (if data available)
Completion date	31/08/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	12 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Patients who have received Romeo®2 / Romeo®2 MIS system for spinal deformities 2. Patients with questionnaires at 22 months or more after surgery with Romeo®2 / Romeo®2 MIS system
Key exclusion criteria	Written opposition by the patients and if applicable their legal representative (for minors) for their data collection for this study
Date of first enrolment	01/03/2026
Date of final enrolment	31/08/2026

Locations

Countries of recruitment

France

Study participating centres

CHU de POITIERS

2 rue de la Milétrie
POITIERS
POITIERS
France

Belharra Clinic

2 Allée Dr Robert Lafon
BAYONNE
64100
France

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

27/01/2026: The methodology, primary and secondary outcomes were updated.
15/01/2026: Study's existence confirmed by the Health Data Hub.