Status:
RECRUITING
Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spondylolisthesis, Lumbar Region
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist. The investigators aim to study the ...
Detailed Description
Due to population aging, lumbar arthrodesis is becoming more frequent in general population. At the same time, those patients need early rehabilitation, even if they do not experiment any motor disabi...
Eligibility Criteria
Inclusion
- Lumbar pain and/or nerve root pain and/or limp without any motor deficiency of the limbs, before and/or after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)
- Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)
- Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and/or nerve root pain and/or limp
- Return home possible after surgery
- After signing consent during pre-operative visit with the surgeon
Exclusion
- People under 18 years-old
- Pregnant or breast-feeding women
- Psychiatric and/or neurodegenerative comorbidity
- Motor deficiency of the limbs before and/or after surgery
- Iliac extension of arthrodesis
- Any postoperative complication lengthening stay at hospital
- Medical contraindication for early rehabilitation
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06129682
Start Date
December 18 2023
End Date
October 1 2028
Last Update
March 19 2025
Active Locations (1)
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1
AP-HP - Hôpital Européen Georges-Pompidou Paris, France
Paris, Île-de-France Region, France, 75908