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

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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, …).
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What it tests

  • Neurolysis peroneal nerve
  • Maximal physiotherapy
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Where

18 sites
AZ Sint-Maarten
Mechelen, Belgium
AZ Turnhout
Turnhout, Belgium
Sint Augustinus
Wilrijk, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
AZ Vesalius
Tongeren, Belgium
AZ Alma
Eeklo, Belgium
AZ Sint-Lucas
Ghent, Belgium
AZ Sint-Jan
Bruges, Belgium

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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