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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN13615218

Enrollment

Registered

2026-01-15

Start date

2026-03-01

Completion date

Unknown

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 Musculoskeletal Diseases

Interventions

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 immob

Eligibility

Sex/Gender

All

Age

12 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Written opposition by the patients and if applicable their legal representative (for minors) for their data collection for this study

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

France

Contacts

Public ContactDervilla Bermingham

clinic@spineart.com+41 (0)225611200

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026