- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926404
UNiD Rods Register
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Caroline Leblanc
- Phone Number: +33472018787
- Email: clinicalstudy@medicrea.com
Study Contact Backup
- Name: Carole Bergougnoux
- Phone Number: +33472018787
- Email: clinicalstudy@medicrea.com
Study Locations
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Tournai, Belgium
- CH WAPI
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-
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Bordeaux, France
- Polyclinique
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Bruges, France
- Orthopôle
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Clermont-Ferrand, France
- Chu Estaing
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Lomme, France
- Hôpital Saint Philibert
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Lyon, France
- Centre Orthopedique Santy
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Lyon, France
- Les Massues
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Marseille, France
- Hôpital La Timone
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Nice, France
- Hopitaux pediatriques - CHU Lenval
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Paris, France
- Hopital Trousseau
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Paris, France
- La pitié Salepetrière Hospital
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Saint-Étienne, France
- Saint Etienne Hospital
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Tarnów, Poland
- Pr Andrzej Maciejczak
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric patients operated with Patient-specific rods
Patients with patient-specific rods (UNiD Rods) <18Years old
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Spinal osteosynthesis
Other Names:
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Adult patients operated with Patient-specific rods
Patients with patient-specific rods (UNiD Rods) >18Years old
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Spinal osteosynthesis
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological performance compared to planning
Time Frame: 12 months
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The primary objective is to compare the planned sagittal parameters with those obtained postoperatively including but not limited to:
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative spinal alignment
Time Frame: 3, 6, 12, 24 months
|
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) |
3, 6, 12, 24 months
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Diasbility
Time Frame: 3, 6, 12, 24 months
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To assess patients' disability through the ODI questionnaire
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3, 6, 12, 24 months
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Quality of life/ SRS-22
Time Frame: 3, 6, 12, 24 months
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To assess patients' quality of life through the SRS-22 questionnaire
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3, 6, 12, 24 months
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Patients' satisfaction
Time Frame: 3, 6, 12, 24 months
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Using a satisfaction questionnaire
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3, 6, 12, 24 months
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Adverse event
Time Frame: 3, 6, 12, 24 months
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To quantify and describe adverse events
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3, 6, 12, 24 months
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Revision
Time Frame: 3, 6, 12, 24 months
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To quantify and describe surgical revisions
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3, 6, 12, 24 months
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Pain/VAS
Time Frame: 3, 6, 12, 24 months
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To assess patients' pain according to VAS : to 0 (better) to 10 (worst)
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3, 6, 12, 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Fiere, MD, Centre Orthopedique Santy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1501 (CSL Behring)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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