Status:
RECRUITING
Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Belgian Health Care Knowledge Centre (KCE)
Conditions:
Peroneal Nerve Entrapment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. Patient...
Detailed Description
The Foot Drop Trial is the first prospective, randomised controlled trial to investigate the treatment of foot drop in peroneal nerve entrapment. Currently, the literature consists mostly of biased re...
Eligibility Criteria
Inclusion
- 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
- 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, …).
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04695834
Start Date
April 28 2021
End Date
December 31 2028
Last Update
July 1 2024
Active Locations (18)
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1
AZ Sint-Maarten
Mechelen, Antwerpen, Belgium, 2800
2
AZ Turnhout
Turnhout, Antwerpen, Belgium, 2300
3
Sint Augustinus
Wilrijk, Antwerpen, Belgium, 2610
4
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500