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New treatment option for Peroneal Nerve Entrapment
Official title Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
ClinicalTrials.gov ID: NCT04695834
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent to participate in the study must be obtained from the subject or proxy / legal representative prior to initiation of any...
- 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 likely can't join if
- people with posttraumatic or iatrogenic peroneal nerve injury
- people 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
See the full eligibility 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
- people with posttraumatic or iatrogenic peroneal nerve injury
- people 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
- people with previous foot drop
- Permanently bedridden people
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Mechelen, Antwerpen, Belgium
- Turnhout, Antwerpen, Belgium
- Wilrijk, Antwerpen, Belgium
- Hasselt, Limburg, Belgium
- Tongeren, Limburg, Belgium
- Eeklo, Oost-Vlaanderen, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Bruges, West-Vlaanderen, Belgium
- Kortrijk, West-Vlaanderen, Belgium
- Ostend, West-Vlaanderen, Belgium
- Roeselare, West-Vlaanderen, Belgium
- Antwerp, Belgium
- Brussels, Belgium
- Genk, Belgium
- Leuven, Belgium
- Liège, Belgium
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mechelen, Antwerpen, Belgium; Turnhout, Antwerpen, Belgium; Wilrijk, Antwerpen, Belgium; Hasselt, Limburg, Belgium; Tongeren, Limburg, Belgium; Eeklo, Oost-Vlaanderen, Belgium and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.