Idiopathic ScoliosisNCT02926404
UNiD Rods Register
An observational study of Idiopathic Scoliosis and Spinal Curvatures, run by Medicrea International at 13 sites in 3 countries.
Trial summary
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis
- What is being tested?
- UNiD Rods
- Type of treatment
- Medical device
- How many people
- 743 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Jan 2015to Oct 2022
- How long will I take part?
- 24 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with spinal deformities
Who may be able to join
- Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL
- Patient affiliated to health care insurance (social security in France)
- Patient able to complete a self-administered questionnaire
- Patient able to sign a disclosure form or a non-opposition form
Who cannot join
- Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL
- Pregnant patient
- Patient not affiliated to health care insurance (social security in France)
- Patient unable to sign a disclosure form
- Patient unable to complete a self-administered questionnaire
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
France11 sites
Polyclinique
Bordeaux
Orthopôle
Bruges
CHU Estaing
Clermont-Ferrand
Hopital Saint Philibert
Lomme
Centre Orthopédique Santy
Lyon
Les Massues
Lyon
Hopital la Timone
Marseille
Hopitaux pediatriques - CHU Lenval
Nice
Hopital Trousseau
Paris
La pitié Salepetrière Hospital
Paris
Saint Etienne Hospital
Saint-Etienne
About this study
Official title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).
This study aims to assess performance, clinical outcomes and safety
Read the detailed description
Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used.
Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.
Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.
A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities
- Being tested
- UNiD Rods
- Keywords
- Sagittal alignment, Surgical planning, Patient-specific, Adult Spinal Deformity
- Medical subject headings
- Spinal Curvatures, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNiD RodsDevice
Also called Patient Specific Rods
Spinal osteosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients operated with Patient-specific rods | Patients with patient-specific rods (UNiD Rods) <18Years old Receives: Device: UNiD Rods | |
| Adult patients operated with Patient-specific rods | Patients with patient-specific rods (UNiD Rods) >18Years old Receives: Device: UNiD Rods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological performance compared to planning
The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to:
- Sagittal vertical axis (SVA)
- Lumbar Lordosis (LL)
- Thoracic Kyphosis (TK)
- Pelvic Tilt (PT)
- Pelvic Incidence (PI)
- Sacral Slope (SS)
- Cobb Angle (CA)
Measured: 12 months
Secondary outcomes (7)
Postoperative spinal alignment
Evaluation of the deformity correction in the sagittal and/or coronal plan. The primary objective is to compare the preoperative sagittal parameters with those obtained postoperatively including but not limited to:
Sagittal vertical axis (SVA) Lumbar Lordosis (LL) Thoracic Kyphosis (TK) Pelvic Tilt (PT) Pelvic Incidence (PI) Sacral Slope (SS) Cobb Angle (CA)
Measured: 3, 6, 12, 24 months
Diasbility
To assess patients' disability through the ODI questionnaire
Measured: 3, 6, 12, 24 months
Quality of life/ SRS-22
To assess patients' quality of life through the SRS-22 questionnaire
Measured: 3, 6, 12, 24 months
Patients' satisfaction
Using a satisfaction questionnaire
Measured: 3, 6, 12, 24 months
Adverse event
To quantify and describe adverse events
Measured: 3, 6, 12, 24 months
Revision
To quantify and describe surgical revisions
Measured: 3, 6, 12, 24 months
Pain/VAS
To assess patients' pain according to VAS : to 0 (better) to 10 (worst)
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2022
- Study completionOct 2022
Why it stopped: Early terminated for administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies 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
- Other
- Enrolment
- 743 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Medicrea International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Fiere, MD, Principal investigator, Centre Orthopédique Santy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926404
- Sponsor's protocol ID
- 1501
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2016
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
- ClinicalTrials.gov ID
- NCT02926404
- Acronym / sponsor ID
- 1501
- Keywords
- Sagittal alignment, Surgical planning, Patient-specific, Adult Spinal Deformity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Early terminated for administrative reasons
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Medicrea InternationalIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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.
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD).
This study aims to assess performance, clinical outcomes and safety
Detailed description
Despite decades of treatment and great diversity of instrumentation, the objective of sagittal spinal realignment in adult spinal deformity is achieved in only 38% of patients which reflects an inadequacy of the approach currently used.
Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.
Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.
A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients operated with Patient-specific rods | – | Device: UNiD RodsPatients with patient-specific rods (UNiD Rods) <18Years old |
| Adult patients operated with Patient-specific rods | – | Device: UNiD RodsPatients with patient-specific rods (UNiD Rods) >18Years old |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with spinal deformities
Key inclusion criteria (4 listed)
- Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL
- Patient affiliated to health care insurance (social security in France)
- Patient able to complete a self-administered questionnaire
- Patient able to sign a disclosure form or a non-opposition form
Key exclusion criteria (5 listed)
- Patient not operated with Patient Specific rods from MEDICREA® INTERNATIONAL
- Pregnant patient
- Patient not affiliated to health care insurance (social security in France)
- Patient unable to sign a disclosure form
- Patient unable to complete a self-administered questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UNiD RodsAlso: Patient Specific RodsSpinal osteosynthesis | Device | Adult patients operated with Patient-specific rods, Pediatric patients operated with Patient-specific rods |
Primary outcome
Radiological performance compared to planning
Time frame: 12 months
The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to: * Sagittal vertical axis (SVA) * Lumbar Lordosis (LL) * Thoracic Kyphosis (TK) * Pelvic Tilt (PT) * Pelvic Incidence (PI) * Sacral Slope (SS) * Cobb Angle (CA)
7 secondary outcomes
Postoperative spinal alignment
Time frame: 3, 6, 12, 24 months
Diasbility
Time frame: 3, 6, 12, 24 months
Quality of life/ SRS-22
Time frame: 3, 6, 12, 24 months
Patients' satisfaction
Time frame: 3, 6, 12, 24 months
Adverse event
Time frame: 3, 6, 12, 24 months
Revision
Time frame: 3, 6, 12, 24 months
Pain/VAS
Time frame: 3, 6, 12, 24 months
Results and safety
The study was stopped early (reason given: Early terminated for administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- 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.
Vincent Fiere, MD principal investigator
Centre Orthopédique Santy
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis and Spinal Curvatures, run by Medicrea International at 13 sites in 3 countries.
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 4 inclusion and 5 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 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium, Poland. 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: Early terminated for administrative reasons). 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?
Radiological performance compared to planning (time frame: 12 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 7 Dec 2023.