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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03194607
Other study ID # GRELAT 2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2016
Est. completion date February 15, 2019

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Low back pain is a leading cause of medical consultations in France and in other industrialized countries. Although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. Yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. To date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. Walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 15, 2019
Est. primary completion date July 30, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patient: - more than 18 years old - who has provided verbal consent - with acquired arthritic lumbar spinal stenosis - eligible for surgery (pain > 3 months, resistant to medical treatment) - for whom the neurosurgeon has scheduled nerve decompression without osteosynthesis or instrumentation - able to walk = 10 metres without help Exclusion Criteria: Patient: - Adult under guardianship - Absence of health insurance cover - Pregnant or breast-feeding women - History of lumbar spinal surgery involving posterior or anterior arthrodesis - History of lumbar spinal surgery involving arthroplasty - History of lumbar spinal surgery within the previous 12 months - Locomotor disorders due to causes other than spine disease (orthopaedic, neurological, vascular, cardiac…) that could significantly affect walking speed - patients in whom the surgery could not be done or deferred (intolerance to the ventral decubitus position, infection…) - patients who had revisit surgery before M6 (with the exception of early revisit surgery during the first month post-intervention) - patients in whom osteosynthesis or the implantation of instruments was decided and done during the surgery

Study Design


Intervention

Other:
Functional walk tests

3D analysis of locomotion and posture

questionnaires


Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the free walking speed in patients (6-minute walk test), before and after surgery 2 weeks and 6 months
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