UNiD Rods Register

NCT02926404 | Terminated

• 1 other identifier: 1501
• Study Type: observational
• Target: 743
• Locations: 3 countries
• Sites: 13

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

Conditions

Idiopathic Scoliosis; Spinal Curvatures; Spondylolisthesis; Degenerative Scoliosis

Keywords

Sagittal alignment; Surgical planning; Patient-specific; Adult Spinal Deformity

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (7)

• Postoperative spinal alignment

  3, 6, 12, 24 months

• Diasbility

  3, 6, 12, 24 months

• Quality of life/ SRS-22

  3, 6, 12, 24 months

• Patients' satisfaction

  3, 6, 12, 24 months

• Adverse event

  3, 6, 12, 24 months

Study Arms (2)

Pediatric patients operated with Patient-specific rods

Patients with patient-specific rods (UNiD Rods) \<18Years old

Device: UNiD Rods

Adult patients operated with Patient-specific rods

Patients with patient-specific rods (UNiD Rods) \>18Years old

Device: UNiD Rods

Interventions

UNiD Rods DEVICE

Spinal osteosynthesis

Also known as: Patient Specific Rods

Adult patients operated with Patient-specific rods; Pediatric patients operated with Patient-specific rods

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with spinal deformities

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medicrea International: lead

Study Sites (13)

CH WAPI

Tournai, Belgium

Location

Polyclinique

Bordeaux, France

Location

Orthopôle

Bruges, France

Location

CHU Estaing

Clermont-Ferrand, France

Location

Hopital Saint Philibert

Lomme, France

Location

Centre Orthopédique Santy

Lyon, France

Location

Les Massues

Lyon, France

Location

Hopital la Timone

Marseille, France

Location

Hopitaux pediatriques - CHU Lenval

Nice, France

Location

Hopital Trousseau

Paris, France

Location

La pitié Salepetrière Hospital

Paris, France

Location

Saint Etienne Hospital

Saint-Etienne, France

Location

Pr Andrzej Maciejczak

Tarnów, Poland

Location

MeSH Terms

Conditions

Spinal Curvatures; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Officials

• Vincent Fiere, MD

  Centre Orthopédique Santy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2015
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); PL (1); FR (11)