Clinical trial NCT04695834: Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
Official title: A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peroneal Nerve Entrapment
Keywords: Peroneal nerve
Neurolysis
Conservative treatment
Randomised controlled trial
Foot drop
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgian Health Care Knowledge Centre (KCE)
First posted: 2021-01-05
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Multi-center Randomized Parallel-group
Primary purpose: TREATMENT

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.

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.

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 retrospective case series with the exception of some small (biased) prospective case series. No comparative trials have been conducted. The goal of the trial is to assess whether foot drop due to peroneal nerve entrapment recovers better 9 months after decompressive surgery compared to maximal conservative treatment.

Patients with persisting foot drop (MRC score ankle dorsiflexion ≤ 3) after 10 +/- 4 weeks after onset of symptoms will be randomised to either decompressive surgery within 1 week after randomisation or maximal conservative treatment focussing on physiotherapy and gait rehabilitation. Blinded outcome assessors will evaluate participants at study visits 10 days (surgical group), 6 weeks, 3 months, 6 months, 9 months (primary outcome) and 18 months (extended follow-up) after randomization.

Outcome assessors will conduct several assessments to evaluate gait improvement (6-minute walk test, 10-meter walk test, Stanmore questionnaire, functional ambulation categories, ability to walk barefoot, need for foot-ankle orthosis), muscle strength (MRC score for ankle dorsiflexion, ankle eversion, hallux extension) , quality of life (EQ-5D 5L) and cost-effectiveness of both treatment strategies (work productivity and activity impairment questionnaire (WPAI), return to work, percentage of invalidity). Electrodiagnostic follow-up will be registered at 3 months and 9 months after randomization.

The primary endpoint of the foot drop trial is the difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization. Time to recovery, defined as the time necessary to cover the minimal age- and sex-specific normal 6MWD AND the time necessary for foot drop recovery to an MRC-score ≥ 4 for ankle dorsiflexion is the key secondary endpoint. No cross-over to surgery is allowed before primary endpoint is reached.

The study first succesfully piloted in 6 centers in Belgium and the Netherlands and is currently starting on a large scale in 20 centers.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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, ...).

Primary outcomes:
measure: The difference in distance covered in meters during the six-minute walk test (6MWD) between baseline and 9 months after randomization.
timeFrame: 9 months
Secondary outcomes:
measure: Time to recovery
timeFrame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
measure: Ankle dorsiflexion strength as measured by the Medical Research Council score (MRC-score).
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
measure: Ankle dorsiflexion strength as measured by isometric dynamometry.
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
measure: Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for hallux extension
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
measure: Complications and neurologic deficits: Sensory changes
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
measure: Gait assessment: Difference in distance covered in meters during the six-minute walk test
timeFrame: 6 weeks, 3 months, 6 months and 18 months (after randomization)
measure: Gait assessment: Stanmore questionnaire
timeFrame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
measure: Gait assessment: Functional ambulation categories
timeFrame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
measure: Gait assessment: Gait speed as measured by the 10-meter walk test
timeFrame: 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
measure: Health economic assessment: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 6 weeks and 6 months after randomization
measure: Complications and neurologic deficits: Surgical complications
timeFrame: 10 days, 6 weeks and 18 months after surgery
measure: Electrodiagnostics: evolution of conduction block at the level of the fibular head
timeFrame: 3 months and 9 months after randomization.
measure: Patient-reported outcome measurements regarding health-related quality of life: 5 Level Euro Quality of Life 5 Dimensions (EQ5D-5L)
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
measure: Health economic assessment: Return to work
timeFrame: 6 weeks
measure: Gait assessment: The proportion of patients in both groups who reach minimal normal age- and sex-specific reference values for distance covered in meters during the six-minute walk test
timeFrame: 9 months after randomization
measure: Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for ankle eversion
timeFrame: 10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Other outcomes:
Locations:
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
state: Antwerpen
city: Turnhout
country: Belgium
facility: AZ Turnhout
state: Antwerpen
city: Wilrijk
country: Belgium
facility: Sint Augustinus
state: Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Limburg
city: Tongeren
country: Belgium
facility: AZ Vesalius
state: Limburg
city: Eeklo
country: Belgium
facility: AZ Alma
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Sint-Lucas
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge, department of neurosurgery
state: West-Vlaanderen
city: Oostende
country: Belgium
facility: AZ Damiaan
state: West-Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: Universitaire Ziekenhuizen Antwerpen
city: Brussels
country: Belgium
facility: ULB Erasme, department of neurosurgery
city: Brussel
country: Belgium
facility: UZ Brussel
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg, department of neurosurgery
city: Leuven
country: Belgium
facility: University Hospitals Of Leuven, department of neurosurgery
city: Liège
country: Belgium
facility: CHU de Liège, department of neurosurgery
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum, department of neurosurgery
Study officials:
affiliation: Univeristy hospitals of Leuven
name: Tom Theys, M.D.; Ph.D.
role: PRINCIPAL_INVESTIGATOR
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