A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The FOOT DROP trial is a prospective, multi-center, randomized controlled trial to assess if decompressive surgery for peroneal nerve entrapment is superior to maximal conservative treatment. Patients with persisting foot drop due to peroneal nerve entrapment will be randomized to either surgery or conservative treatment if foot drop persists 10 +/- 4 weeks after onset of symptoms. Patients will be evaluated through several questionnaires, evolution of muscle strength and several types of gait assessments. Primary endpoint is the difference in distance covered during the six minute walking test between baseline and 9 months after randomization.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Written informed consent to participate in the study must be obtained from the subject or proxy / legal representative prior to initiation of any study-mandated procedure
• EDX-documented peroneal nerve entrapment with persisting (10 ± 4 weeks) foot drop (MRC-score ≤ 3)
• Imaging (ultrasound/MRI) performed to exclude a compressive mass
• Age ≥ 18 years
Locations
Other Locations
Belgium
Universitaire Ziekenhuizen Antwerpen
NOT_YET_RECRUITING
Antwerp
AZ Sint-Jan
NOT_YET_RECRUITING
Bruges
ULB Erasme, department of neurosurgery
RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
AZ Alma
NOT_YET_RECRUITING
Eeklo
Ziekenhuis Oost-Limburg, department of neurosurgery
RECRUITING
Genk
AZ Sint-Lucas
NOT_YET_RECRUITING
Ghent
Jessa Ziekenhuis
NOT_YET_RECRUITING
Hasselt
AZ Groeninge, department of neurosurgery
RECRUITING
Kortrijk
University Hospitals Of Leuven, department of neurosurgery
RECRUITING
Leuven
CHU de Liège, department of neurosurgery
RECRUITING
Liège
AZ Sint-Maarten
NOT_YET_RECRUITING
Mechelen
AZ Damiaan
NOT_YET_RECRUITING
Ostend
AZ Delta
NOT_YET_RECRUITING
Roeselare
AZ Vesalius
NOT_YET_RECRUITING
Tongeren
AZ Turnhout
NOT_YET_RECRUITING
Turnhout
Sint Augustinus
NOT_YET_RECRUITING
Wilrijk
Netherlands
Leids Universitair Medisch Centrum, department of neurosurgery
RECRUITING
Leiden
Contact Information
Primary
Christophe Oosterbos, M.D.
christopheoosterbos@gmail.com
+3216344290
Backup
Tom Theys, M.D.; Ph.D.
tom.theys@uzleuven.be
+3216344290
Time Frame
Start Date:2021-04-28
Estimated Completion Date:2028-12-31
Participants
Target number of participants:182
Treatments
Active_comparator: Conservative treatment
Patients that are randomized to the conservative arm of the trial. These patients will not be operated until primary endpoint is reached.~If necessary, cross-over can occur after primary endpoint is reached.~Conservative treatment is considered standard of care.
Active_comparator: Surgical treatment
Patients randomized to the surgical arm will be operated within 1 week after randomization (if possible within 2 days).~Neurolysis is considered standard of care.