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.
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
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
Parallel
Neurolysis peroneal nerve
Procedure/SurgeryThe 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
Maximal physiotherapy
Other interventionMobilization 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
The difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization.
Based on a literature analysis and patient feedback on the trial design, gait analysis and recovery of a normal gait pattern are crucial in the recovery of foot drop. In 90% of interviewed patients, success of treatment was related to improvement in gait. The distance covered during the six-minute walk test (6MWT) is validated and clinically used in gait analysis. 6MWT: patients are instructed to walk as far as possible within six minutes (strokes of 30 meters of more). The minimal age- and sex-specific normal 6MWD is defined as 82% of the applied reference equations for prediction of the 6MWD. The reference value that will be used is 6MWDpred(m) = 868.8 - (ageyears x 2.99) - (gender x 74.7). The value for gender is 0 in male subjects and 1 in female subjects.
Time to recovery
KEY SECONDARY ENDPOINT Time to recovery is defined as: the time necessary to cover the minimal age- and sex-specific normal distance in meters during the 6-minute walking test (6MWT) AND the time necessary for foot drop recovery to an MRC-score ≥ 4 for ankle dorsiflexion. The MRC-score is a clinical assessment of muscle strength. MRC-ranges from 0 to 5 with zero indicating no movement at all and 5 indicating normal muscle strength. The minimal age- and sex-specific normal 6-minute walking distance (6MWD) is defined as 82% of the applied reference equations for prediction of the 6MWD. The reference value that will be used is 6MWDpred(m) = 868.8 - (ageyears x 2.99) - (gender x 74.7). The value for gender is 0 in male subjects and 1 in female subjects.
Ankle dorsiflexion strength as measured by the Medical Research Council score (MRC-score).
Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5. 0: no movement 1. contraction of muscle, but no movement 2. movement, but not against gravity 3. movement against gravity, but not against resistance 4. movement against resistance 5. normal strength
Ankle dorsiflexion strength as measured by isometric dynamometry.
Recovery of ankle dorsiflexion strength is essential in patients with foot drop. The use of dynamometry allows to document ankle dorsiflexion strength in an objective manner. Patients are asked to lay in supine position, with the knees extended. The test pad of the dynamometer is placed on the dorsal head of the first metatarsal bone. The patient is instructed to perform ankle dorsiflexion with maximal muscle strength. The best of three attempts is registered. Ankle dorsiflexion is measured and reported in both ankles (in kilograms). The ankle dorsiflexion strength ratio, defined as the ratio of ankle dorsiflexion strength in the affected ankle over ankle dorsiflexion strength in the healthy ankle will be calculated and reported
Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for hallux extension
Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5. 0: no movement 1. contraction of muscle, but no movement 2. movement, but not against gravity 3. movement against gravity, but not against resistance 4. movement against resistance 5. normal strength
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Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Belgian Health Care Knowledge Centre (KCE)
Collaborator
