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Trial record 31 of 42 for:    Recruiting, Not yet recruiting, Available Studies | "Spondylolisthesis"

UNiD Rods Register

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ClinicalTrials.gov Identifier: NCT02926404
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medicrea International

Brief 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


Condition or disease Intervention/treatment
Scoliosis Spinal Curvatures Spondylolisthesis Device: UNiD Rods

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 [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
Study Start Date : July 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Patient-specific rods
Patients with spinal deformities receiving osteosynthesis with patient-specific rods (UNiD Rods)
Device: UNiD Rods
Spinal osteosynthesis
Other Name: Patient Specific Rods




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


  2. Pain [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' pain according to VAS

  3. Diasbility [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' disability through the ODI questionnaire

  4. Quality of life [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' quality of life through the SRS-22 questionnaire

  5. Patients' satisfaction [ Time Frame: 3, 6, 12, 24 months ]
    Using a satisfaction questionnaire

  6. Adverse event [ Time Frame: 3, 6, 12, 24 months ]
    To quantify and describe adverse events

  7. Revision [ Time Frame: 3, 6, 12, 24 months ]
    To quantify and describe surgical revisions



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with spinal deformities
Criteria

Inclusion Criteria:

  • Patient operated with UNiD® Patient Specific rods from MEDICREA® INTERNATIONAL for :

    • Scoliosis or kyphosis deformity or
    • Spondylolisthesis or
    • confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
  • 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
  • Patient not operated for scoliosis or kyphosis deformity, spondylolisthesis nor confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926404


Contacts
Contact: Estelle Douceron, PhD +33472018787 clinicalstudy@medicrea.com
Contact: Carole Bergougnoux +33472018787 clinicalstudy@medicrea.com

Locations
France
Hopital Saint Philibert Not yet recruiting
Lomme, France
Contact: Denis Cordonnier, MD         
Centre Orthopédique Santy Recruiting
Lyon, France
Contact: Vincent Fiere, MD         
Clinique du Parc Recruiting
Lyon, France
Contact: Alexandre Journé, MD         
Hopital la Timone Not yet recruiting
Marseille, France
Contact: Benjamin Blondel, MD         
Principal Investigator: Stéphane Fuentes, MD         
Hopitaux pediatriques - CHU Lenval Not yet recruiting
Nice, France
Contact: Jean-Luc Clément, MD         
Hopital Trousseau Recruiting
Paris, France
Contact: Reda Kabbaj, MD         
Sponsors and Collaborators
Medicrea International
Investigators
Principal Investigator: Vincent Fiere, MD Centre Orthopédique Santy

Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT02926404     History of Changes
Other Study ID Numbers: 1501
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Medicrea International:
Sagittal alignment
Surgical planning
Patient-specific
Adult Spinal Deformity

Additional relevant MeSH terms:
Scoliosis
Spondylolisthesis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis