Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve

Recruiting now · Not applicable

Conditions studied: Peroneal Nerve Entrapment

In brief

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.

Key facts

Study ID

NCT04695834

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

182

Starts

2021-04-28

Expected to finish

2028-12-31

Last updated by the study team

2024-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Psychiatric illness
• Pregnancy
• Planned (e)migration within 1 year after randomization to another country
• Subjects with previous foot drop
• Permanently bedridden subjects
• Subjects with neurological or musculoskeletal history which could impact foot drop assessment and/or gait analysis (e.g. polyneuropathy, hereditary neuropathy with pressure palsies, critical illness polyneuropathy, previous stroke, ankle surgery, …).

Where it is running

• ULB Erasme, department of neurosurgery — Brussels, Belgium (enrolling)
• AZ Groeninge, department of neurosurgery — Kortrijk, West-Vlaanderen, Belgium (enrolling)
• Ziekenhuis Oost-Limburg, department of neurosurgery — Genk, Belgium (enrolling)
• University Hospitals Of Leuven, department of neurosurgery — Leuven, Belgium (enrolling)
• CHU de Liège, department of neurosurgery — Liège, Belgium (enrolling)
• Leids Universitair Medisch Centrum, department of neurosurgery — Leiden, Netherlands (enrolling)
• AZ Sint-Lucas — Ghent, Oost-Vlaanderen, Belgium
• AZ Sint-Jan — Bruges, West-Vlaanderen, Belgium
• AZ Sint-Maarten — Mechelen, Antwerpen, Belgium
• AZ Delta — Roeselare, West-Vlaanderen, Belgium
• Universitaire Ziekenhuizen Antwerpen — Antwerp, Belgium
• UZ Brussel — Brussels, Belgium
• AZ Damiaan — Ostend, West-Vlaanderen, Belgium
• AZ Turnhout — Turnhout, Antwerpen, Belgium
• Sint Augustinus — Wilrijk, Antwerpen, Belgium
• Jessa Ziekenhuis — Hasselt, Limburg, Belgium
• AZ Vesalius — Tongeren, Limburg, Belgium
• AZ Alma — Eeklo, Oost-Vlaanderen, Belgium

Full record on ClinicalTrials.gov

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