FOOT DROP TRIAL

A prospective, multi-center, randomized, parallel-group controlled trial to compare conservative versus surgical treatment of foot drop in peroneal nerve entrapment

Chirurgen tijdens operatie
Fysiotherapie

INCLUSION CRITERIA

EXCLUSION 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

  • Posttraumatic, iatrogenic or bilateral peroneal nerve injury

  • Peroneal neuropathy due to a compressive mass (e.g. cyst, tumour)

  • Peroneal nerve entrapment at other sites than the fibular head

  • Mental or physical problems that incapacitate them to participate in a physiotherapy program

  • 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, previous stroke, ankle surgery, ankle sprain, …).

FACTS AND FIGURES

"The best treatment remains unknown. There is a need for a randomized controlled trial to determine which treatment is superior."

Best treatment unknown.png
Best treatment unknown.png

PRELIMINARY RESULTS

of the FOOT DROP  Survey

This survey wants to map current management strategies in peroneal nerve entrapment among neurosurgeons, neurologists and physical medicine and rehabiliation physicians worldwide. 

Preliminary results are based on answers of 139 specialists.

"Daily practice is based on personal beliefs and experiences."

Daily practice based on .png
Daily practice based on .png

NEWS

12th of May 2021

First patient randomized

1st of June 2021

First Trial Steering Committee (TSC)

BEYOND FOOT DROP

FURTHER RESEARCH

FOOT DROP SURVEY

IMAFIB
IMAging of the FIBular nerve

There is insufficient evidence in the literature to make any recommendations regarding treatment of foot drop in peroneal nerve entrapment. Most patient series are retrospective in nature and suffer from significant bias. This is a reflection of daily practice. Current management strategies are mostly based on experience and personal beliefs of the treating physician. This survey wants to map current management strategies in peroneal nerve entrapment, to document the differences between centers and between different specialists. The results of this survey are meant to support the development of the FOOT DROP trial.

Although peroneal neuropathy represents the most common neuropathy in the lower limb, there is insufficient data in the available literature to make any treatment recommendations.  Meanwhile, there is an increasing role for conventional imaging (high frequency ultrasound and MR neurography) in diagnosing peroneal nerve entrapment. This imaging study will assess the utility of different imaging modalities (high frequency ultrasound, MR neurography, fMRI and DTI) in diagnosing peroneal neuropathies, in the follow-up of peroneal neuropathy and in predicting outcome in peroneal neuropathies. Moreover, this study will investigate which imaging modality is superior in the follow-up and for outcome prediction in peroneal neuropathy.

Key team members

Dr. Christophe Oosterbos
Trial Coordinator
Prof. dr. Tom Theys
Chief Investigator
Clinical Trial Assistant
Sophie Hoornaert

Endorsed by