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.
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
Subjects with posttraumatic or iatrogenic peroneal nerve injury
Subjects with peroneal neuropathy due to a compressive mass (e.g. cyst, tumour)
Peroneal nerve entrapment at other sites than the fibular head
Patients with mental or physical problems that incapacitate them to participate in a physiotherapy program
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Belgian Health Care Knowledge Centre (KCE)
Collaborator