Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
Universitaire Ziekenhuizen KU Leuven
182 participants
Apr 28, 2021
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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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Interventions
The surgical approach for entrapment at the fibular head is usually through a curvilinear incision just distal to the fibular head. The subcutaneous tissue is bluntly dissected, and the common peroneal nerve is identified proximal to the peroneus longus muscle. The peroneal nerve is then released from the surrounding fibrous tissue and fascia. The nerve is decompressed distally as it dives under the peroneus longus muscle. The decompression at this site is essential. Certain authors state that an adequate decompression should extend beyond the bifurcation in the deep and superficial peroneal nerve and should involve cutting the intermuscular septa
Mobilization of ankle and foot, stretching of the calf muscles (prevention of contractures) Tonification of the dorsiflexion- and eversion muscles of the ankle Proprioceptive training Gait rehabilitation Home exercise schedule
Locations(18)
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NCT04695834