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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

Tracking Information
First Submitted Date June 27, 2016
First Posted Date October 6, 2016
Last Update Posted Date March 21, 2018
Study Start Date July 2014
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 5, 2016)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02926404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 5, 2016)
  • 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)
  • Pain [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' pain according to VAS
  • Diasbility [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' disability through the ODI questionnaire
  • Quality of life [ Time Frame: 3, 6, 12, 24 months ]
    To assess patients' quality of life through the SRS-22 questionnaire
  • Patients' satisfaction [ Time Frame: 3, 6, 12, 24 months ]
    Using a satisfaction questionnaire
  • Adverse event [ Time Frame: 3, 6, 12, 24 months ]
    To quantify and describe adverse events
  • Revision [ Time Frame: 3, 6, 12, 24 months ]
    To quantify and describe surgical revisions
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title UNiD Rods Register
Official Title Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
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

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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patient with spinal deformities
Condition
  • Scoliosis
  • Spinal Curvatures
  • Spondylolisthesis
Intervention Device: UNiD Rods
Spinal osteosynthesis
Other Name: Patient Specific Rods
Study Groups/Cohorts Patient-specific rods
Patients with spinal deformities receiving osteosynthesis with patient-specific rods (UNiD Rods)
Intervention: Device: UNiD Rods
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 5, 2016)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Estelle Douceron, PhD +33472018787 clinicalstudy@medicrea.com
Contact: Carole Bergougnoux +33472018787 clinicalstudy@medicrea.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02926404
Other Study ID Numbers 1501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Medicrea International
Study Sponsor Medicrea International
Collaborators Not Provided
Investigators
Principal Investigator: Vincent Fiere, MD Centre Orthopédique Santy
PRS Account Medicrea International
Verification Date March 2018