UNiD Rods Register

November 30, 2023 updated by: Medicrea International

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

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

Observational

Enrollment (Actual)

743

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Tournai, Belgium
        • CH WAPI
      • Bordeaux, France
        • Polyclinique
      • Bruges, France
        • Orthopôle
      • Clermont-Ferrand, France
        • Chu Estaing
      • Lomme, France
        • Hôpital Saint Philibert
      • Lyon, France
        • Centre Orthopedique Santy
      • Lyon, France
        • Les Massues
      • Marseille, France
        • Hôpital La Timone
      • Nice, France
        • Hopitaux pediatriques - CHU Lenval
      • Paris, France
        • Hopital Trousseau
      • Paris, France
        • La pitié Salepetrière Hospital
      • Saint-Étienne, France
        • Saint Etienne Hospital
      • Tarnów, Poland
        • Pr Andrzej Maciejczak

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with spinal deformities

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Spinal osteosynthesis
Other Names:
  • Patient Specific Rods
Adult patients operated with Patient-specific rods
Patients with patient-specific rods (UNiD Rods) >18Years old
Spinal osteosynthesis
Other Names:
  • Patient Specific Rods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

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
Diasbility
Time Frame: 3, 6, 12, 24 months
To assess patients' disability through the ODI questionnaire
3, 6, 12, 24 months
Quality of life/ SRS-22
Time Frame: 3, 6, 12, 24 months
To assess patients' quality of life through the SRS-22 questionnaire
3, 6, 12, 24 months
Patients' satisfaction
Time Frame: 3, 6, 12, 24 months
Using a satisfaction questionnaire
3, 6, 12, 24 months
Adverse event
Time Frame: 3, 6, 12, 24 months
To quantify and describe adverse events
3, 6, 12, 24 months
Revision
Time Frame: 3, 6, 12, 24 months
To quantify and describe surgical revisions
3, 6, 12, 24 months
Pain/VAS
Time Frame: 3, 6, 12, 24 months
To assess patients' pain according to VAS : to 0 (better) to 10 (worst)
3, 6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vincent Fiere, MD, Centre Orthopedique Santy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimated)

October 6, 2016

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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