UNiD Rods Register

Terminated

• Conditions: Spondylolisthesis; Degenerative Scoliosis; Idiopathic Scoliosis; Spinal Curvatures
• Interventions: Device: UNiD Rods

• Registration Number: NCT02926404
• Lead Sponsor: 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

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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 743

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients operated with Patient-specific rods	UNiD Rods	Patients with patient-specific rods (UNiD Rods) \<18Years old
Adult patients operated with Patient-specific rods	UNiD Rods	Patients with patient-specific rods (UNiD Rods) \>18Years old

Primary Outcome Measures

Name	Time	Method
Radiological performance compared to planning	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

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

Trial Locations

Locations (13)

CH WAPI; 🇧🇪 Tournai, Belgium

Pr Andrzej Maciejczak; 🇵🇱 Tarnów, Poland

Orthopôle; 🇫🇷 Bruges, France

CHU Estaing; 🇫🇷 Clermont-Ferrand, France

Hopital Saint Philibert; 🇫🇷 Lomme, France

Centre Orthopédique Santy; 🇫🇷 Lyon, France

La pitié Salepetrière Hospital; 🇫🇷 Paris, France

Saint Etienne Hospital; 🇫🇷 Saint-Étienne, France

Hopital Trousseau; 🇫🇷 Paris, France

Hopital la Timone; 🇫🇷 Marseille, France

Les Massues; 🇫🇷 Lyon, France

Polyclinique; 🇫🇷 Bordeaux, France

Hopitaux pediatriques - CHU Lenval; 🇫🇷 Nice, France