Clinical trial NCT02926404: UNiD Rods Register
Official title: Evaluation of Patients Treated With Patient Specific Rods: UNiD Rods Register
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Idiopathic Scoliosis
Spinal Curvatures
Spondylolisthesis
Degenerative Scoliosis
Keywords: Sagittal alignment
Surgical planning
Patient-specific
Adult Spinal Deformity
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2016-10-06
Enrollment: 743
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with spinal deformities

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

Eligibility criteria: 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

Primary outcomes:
measure: Radiological performance compared to planning
timeFrame: 12 months
Secondary outcomes:
measure: Postoperative spinal alignment
timeFrame: 3, 6, 12, 24 months
measure: Diasbility
timeFrame: 3, 6, 12, 24 months
measure: Quality of life/ SRS-22
timeFrame: 3, 6, 12, 24 months
measure: Patients' satisfaction
timeFrame: 3, 6, 12, 24 months
measure: Adverse event
timeFrame: 3, 6, 12, 24 months
measure: Revision
timeFrame: 3, 6, 12, 24 months
measure: Pain/VAS
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Tournai
country: Belgium
facility: CH WAPI
city: Bordeaux
country: France
facility: Polyclinique
city: Bruges
country: France
facility: Orthopôle
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Lomme
country: France
facility: Hopital Saint Philibert
city: Lyon
country: France
facility: Centre Orthopédique Santy
city: Lyon
country: France
facility: Les Massues
city: Marseille
country: France
facility: Hopital la Timone
city: Nice
country: France
facility: Hopitaux pediatriques - CHU Lenval
city: Paris
country: France
facility: Hopital Trousseau
city: Paris
country: France
facility: La pitié Salepetrière Hospital
city: Saint-Étienne
country: France
facility: Saint Etienne Hospital
city: Tarnów
country: Poland
facility: Pr Andrzej Maciejczak
Study officials:
affiliation: Centre Orthopédique Santy
name: Vincent Fiere, MD
role: PRINCIPAL_INVESTIGATOR
References: