Neuro-Orthopedic Registry of the University Hospital of Toulouse

Neuro-orthopedics corresponds to the evaluation and therapeutic management of the orthopedic consequences of damage to the central or peripheral nervous system. In case of neurological impairment, there may be joint, motor, sensory and cognitive impairments that limit the patient's activities. The management of these orthopedic problems falls within the specific framework of neuro-orthopedics because in the presence of neurological, problems are different and more complex than in classical orthopedics. In this context, a well-conducted evaluation is a prerequisite for appropriate treatment.

Study Overview

• Status: Completed
• Conditions: Neurologic Disorder
• Intervention / Treatment: Other: Data collection

• Study Type: Observational
• Enrollment (Actual): 976

Contacts and Locations

Study Locations

• France
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31059
      • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with central or peripheral nervous system disorders with orthopedic consequences.

Description

Inclusion Criteria:

Patient with a neurological condition that benefits:

• An injection of botulinum toxin in the context of spasticity : about 20 / week
• Pre or post-therapeutic clinical evaluation (botulinum toxin or surgery): approximately 10 / week
• Clinical or instrumental evaluation of the walking or upper limb (Physiological Functional Explorations): about 10 / week
• A medical and surgical multidisciplinary consultation about spasticity : about 15 / month
• A discussion during neuroorthopedic multidisciplinary consultation meeting about the patient's file and anomalies of walking: about 8 / month
• Implementation of a Baclofen pump (Neurosurgery): about 2 / month
• Functional surgery of the upper or lower limb (locomotor institute, orthopedic surgery and traumatology): about 4 / sem

Exclusion Criteria:

Patient (or the legal representative) who opposes the data collection.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients group; Patients follow-up in hospital will have data collection	Other: Data collection; data collection about symptoms without any specific clinical or biological intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic symptoms	Data collection	Each year until five years

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Ipsen
• Investigators: Principal Investigator: David Gasq, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Register; Neuro-Orthopedics
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: 14 7321 03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No