UNiD Rods Register

Spondylolisthesis Clinical Trial

Official title:

Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02926404
• Other study ID #: 1501
• Status: Terminated
• Start date: January 2015
• Est. completion date: October 2022

Study information

• Verified date: November 2023
• Source: Medicrea International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 743
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Scoliosis
• Idiopathic Scoliosis
• Scoliosis
• Spinal Curvatures
• Spondylolisthesis

Intervention

Device:
• UNiD Rods
Spinal osteosynthesis

Locations

Country	Name	City	State
Belgium	CH WAPI	Tournai
France	Polyclinique	Bordeaux
France	Orthopôle	Bruges
France	CHU Estaing	Clermont-Ferrand
France	Hopital Saint Philibert	Lomme
France	Centre Orthopédique Santy	Lyon
France	Les Massues	Lyon
France	Hopital la Timone	Marseille
France	Hopitaux pediatriques - CHU Lenval	Nice
France	Hopital Trousseau	Paris
France	La pitié Salepetrière Hospital	Paris
France	Saint Etienne Hospital	Saint-Étienne
Poland	Pr Andrzej Maciejczak	Tarnów

Sponsors (1)

Lead Sponsor	Collaborator
Medicrea International

Countries where clinical trial is conducted

Belgium,  France,  Poland, 

Outcome

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