Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve (FOOTDROP)

A Prospective, Multi-center, Randomized, Parallel-group Controlled Trial to Compare Conservative Versus Surgical Treatment of Foot Drop in Peroneal Nerve Entrapment.

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.

Study Overview

• Status: Recruiting
• Conditions: Peroneal Nerve Entrapment
• Intervention / Treatment: Other: Maximal physiotherapy; Procedure: Neurolysis peroneal nerve

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.

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe Oosterbos, M.D.; Phone Number: +3216344290; Email: christopheoosterbos@gmail.com
• Study Contact Backup: Name: Tom Theys, M.D.; Ph.D.; Phone Number: +3216344290; Email: tom.theys@uzleuven.be

Study Locations

• Belgium
  • Antwerpen, Belgium, 2000
    • Not yet recruiting
    • Universitaire Ziekenhuizen Antwerpen
    • Contact: Tomas Menovsky, M.D.: PhD; Phone Number: +323 821 33 28
    • Principal Investigator: Tomas Menovsky, M.D.: PhD
  • Brussel, Belgium, 1000
    • Not yet recruiting
    • UZ Brussel
    • Contact: Johhny Duerinck, M.D.; PhD; Phone Number: +322 477 60 12
    • Principal Investigator: Johnny Duerinck, M.D.; PhD
  • Brussels, Belgium, 1000
    • Recruiting
    • ULB Erasme, department of neurosurgery
    • Contact: Sophie Schuind, M.D.; Email: sophie.schuind@ulb.erasme.ac.be
    • Principal Investigator: Sophie Schuind, M.D.
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg, department of neurosurgery
    • Contact: Frank Weyns, M.D.; Phone Number: +3289326043; Email: frank.weyns@zol.be
    • Principal Investigator: Frank Weyns, M.D.
  • Leuven, Belgium, 3000
    • Recruiting
    • University Hospitals Of Leuven, department of neurosurgery
    • Contact: Tom Theys, M.D., Ph.D.; Phone Number: +3216344290; Email: tom.theys@uzleuven.be
    • Principal Investigator: Tom Theys, M.D.; Ph.D.
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège, department of neurosurgery
    • Contact: Annie Dubuisson, M.D., Ph.D.; Email: a.dubuisson@chuliege.be
    • Principal Investigator: Annie Dubuisson, M.D.; Ph.D.
  • Antwerpen
    • Mechelen, Antwerpen, Belgium, 2800
      • Not yet recruiting
      • Az Sint-Maarten
      • Contact: Pieter Jan Van Dyck - Lippens, M.D.; Phone Number: +3215891010
      • Principal Investigator: Pieter Jan Van Dyck - Lippens, M.D.
    • Turnhout, Antwerpen, Belgium, 2300
      • Not yet recruiting
      • AZ Turnhout
      • Contact: Jens Deckers, M.D.; Phone Number: +3214406184
      • Principal Investigator: Jens Deckers, M.D.
    • Wilrijk, Antwerpen, Belgium, 2610
      • Not yet recruiting
      • Sint Augustinus
      • Contact: Tony Van Havenbergh, M.D.; PhD; Email: info@neurochirurgiegroep.be
      • Principal Investigator: Tony Van Havenbergh, M.D.; PhD
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Not yet recruiting
      • Jessa Ziekenhuis
      • Contact: Gert Roosen, M.D.; Phone Number: +3211335511
      • Principal Investigator: Gert Roosen, M.D.
    • Tongeren, Limburg, Belgium, 3717
      • Not yet recruiting
      • AZ Vesalius
      • Contact: Louise Schoolderman, M.D.; Phone Number: +3212397912
      • Principal Investigator: Louise Schoolderman, M.D.
  • Oost-Vlaanderen
    • Eeklo, Oost-Vlaanderen, Belgium, 9900
      • Not yet recruiting
      • AZ Alma
      • Contact: Kristel Vanchaze, M.D.; Phone Number: +329 310 19 69
      • Principal Investigator: Kristel Vanchaze, M.D.
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Not yet recruiting
      • AZ Sint-Lucas
      • Principal Investigator: Kristel Vanchaze, M.D.
      • Contact: Kristel Vanchaze, M.D.; Email: secretariaat.neurochirurgie@azstlucas.be
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8000
      • Not yet recruiting
      • AZ Sint-Jan
      • Contact: Nikolaas Vantomme, M.D.; Phone Number: +3250452300
      • Principal Investigator: Nikolaas Vantomme, M.D.
    • Kortrijk, West-Vlaanderen, Belgium, 8500
      • Recruiting
      • AZ Groeninge, department of neurosurgery
      • Contact: Jeroen Ceuppens, M.d.; Email: jeroen.ceuppens@azgroeninge.be
      • Principal Investigator: Jeroen Ceuppens, M.D.
    • Oostende, West-Vlaanderen, Belgium, 8400
      • Not yet recruiting
      • AZ Damiaan
      • Contact: Adinda De Pauw, M.D.; Phone Number: +3259414060
      • Principal Investigator: Adinda De Pauw, M.D.
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Not yet recruiting
      • AZ Delta
      • Contact: Jeroen Van Lerbeirghe, M.D.; Email: secr.neurochirurgie.rumbeke@azdelta.be
      • Principal Investigator: Jeroen Van Leirberghe, M.D.
• Netherlands
  • Leiden, Netherlands, 2333
    • Recruiting
    • Leids Universitair Medisch Centrum, department of neurosurgery
    • Contact: Justus Groen, M.D.; Email: J.L.Groen@lumc.nl
    • Principal Investigator: Justus Groen, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, …).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment; Patients that are randomized to the conservative arm of the trial. These patients will not be operated until primary endpoint is reached. If necessary, cross-over can occur after primary endpoint is reached. Conservative treatment is considered standard of care.	Other: Maximal physiotherapy; 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
Active Comparator: Surgical treatment; Patients randomized to the surgical arm will be operated within 1 week after randomization (if possible within 2 days). Neurolysis is considered standard of care.	Procedure: Neurolysis peroneal nerve; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
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; contraction of muscle, but no movement; movement, but not against gravity; movement against gravity, but not against resistance; movement against resistance; normal strength	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
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	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
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; contraction of muscle, but no movement; movement, but not against gravity; movement against gravity, but not against resistance; movement against resistance; normal strength	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Complications and neurologic deficits: Sensory changes	In a large retrospective patient series on peroneal nerve decompression after weight loss, Broekx et al. (2018) examined the recovery of sensory deficits. Symptoms qualified as sensory included the presence of hypoesthesia and/or paresthesia. They used the following system to assess sensory symptoms: Complete recovery: the absence of any sensory symptoms; Partial recovery: patients with a minimum of sensory symptoms; No recovery: patients with no improvement	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))
Gait assessment: Difference in distance covered in meters during the six-minute walk test	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.	6 weeks, 3 months, 6 months and 18 months (after randomization)
Gait assessment: Stanmore questionnaire	The Stanmore questionnaire has been used in the literature to assess functional outcome in patients with foot drop due to peroneal nerve injury. Seven sections (pain, need for orthosis, normal shoes, functional outcome, muscle power, degree of active dorsiflexion and foot posture) add up to a sum score of 100 points.	6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Gait assessment: Functional ambulation categories	Functional ambulation categories (FAC) is a useful scale to assess gait in patients with foot drop. It is a six point scale, that is used in stroke literature and can help determine how much assistance a patient requires. FAC 0 reflects a nonfunctional state and FAC 5 equals a normal gait pattern.	6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Gait assessment: Gait speed as measured by the 10-meter walk test	Walking speed is an important aspect of gait and is often used as an objective measure of functional mobility. The 10-meter walk test is a commonly used and validated tool to assess gait speed.	6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Work Productivity and Activity Impairment Questionnaire (WPAI)	Health economic aspects of foot drop will be evaluated through the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI is widely used and validated in multiple languages. The WPAI questionnaire consists of 6 questions with regard to professional activity during the past 7 days.	6 weeks and 6 months after randomization
Complications and neurologic deficits: Surgical complications	A list of possible complications is made available to all participating centers. Unforeseen complications will be recorded as free-text.	10 days, 6 weeks and 18 months after surgery
Electrodiagnostics: evolution of conduction block at the level of the fibular head	All patients will have repeated electrodiagnostic examinations. The evolution of the conduction block at the level of the fibular head will be documented in the eCRF.	3 months and 9 months after randomization.
Patient-reported outcome measurements regarding health-related quality of life: 5 Level Euro Quality of Life 5 Dimensions (EQ5D-5L)	The EQ-5D 5L is a generic measure of health-related quality of life developed by the EuroQol Group. It is a validated measurement of quality of life widely used in different pathologies. The questionnaire is made up of two parts. The first part is descriptive and uses five different dimensions to score quality of life. These five dimensions are mobility, self-care, activities of the daily life, pain/discomfort and anxiety/depression. There are five different answer possibilities within each dimension, i.e. "no problem", "slight problem", "moderate problem", "severe problem" and "unable to". This renders 3125 different answer possibilities. The second part uses a visual analogue scale (VAS) to score the current health status of the patient, ranging from zero to one hundred. Zero corresponds to death and one hundred corresponds to a (subjective) perfect health status.	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)
Health economic assessment: Return to work	Health economic aspects will also be evaluated through the assessment of return to work. We expect subgroups of patients with foot drop to be unable to work. Once the foot drop has improved (or fully recovered), we expect patients to be able to return to work and to not experience any more related problems (after their initial recovery). In this trial population foot drop does in general not represent a chronic condition with periods of relapse. Either the foot drop recovers enough to be able to work again, or the foot drop does not sufficiently recover to resume previous professional activities. Taking this into account, return to work seems to represent a very important measure. Patients will be asked about return to work at the study visit six weeks after randomization. To avoid recall bias, patients will be asked in advance to record the date of return to work. During baseline assessments, subjects will be questioned if they are incapacitated to work due to the foot drop and the	6 weeks
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	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.	9 months after randomization
Complications and neurologic deficits: Motor changes as assessed by the Medical Research Council Score (MRC-score) for ankle eversion	Medical Research Council (MRC)-score as clinical assessment of muscle strength. MRC-score ranges from 0 to 5. 0: no movement; contraction of muscle, but no movement; movement, but not against gravity; movement against gravity, but not against resistance; movement against resistance; normal strength	10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Belgian Health Care Knowledge Centre (KCE)
• Investigators: Principal Investigator: Tom Theys, M.D.; Ph.D., Univeristy hospitals of Leuven

Publications and helpful links

General Publications

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• Poppler LH, Bansal A, Groves A, Sacks G, Davidge K, Mackinnon SE. Abstract 65: Subclinical Peroneal Nerve Entrapment May be an Under-recognized Cause of Falls in Hospitalized Patients. Plast Reconstr Surg. 2014 Mar;133(3 Suppl):76. doi: 10.1097/01.prs.0000445098.29964.cf. No abstract available.
• Aprile I, Caliandro P, La Torre G, Tonali P, Foschini M, Mondelli M, Bertolini C, Piazzini DB, Padua L. Multicenter study of peroneal mononeuropathy: clinical, neurophysiologic, and quality of life assessment. J Peripher Nerv Syst. 2005 Sep;10(3):259-68. doi: 10.1111/j.1085-9489.2005.10304.x.
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• Sipahioglu S, Zehir S, Askar H, Isikan UE. Peroneal nerve palsy secondary to prolonged squatting in seasonal farmworkers. Acta Orthop Traumatol Turc. 2015;49(1):45-50. doi: 10.3944/AOTT.2015.14.0074.
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• Nirenberg MS. A simple test to assist with the diagnosis of common fibular nerve entrapment and predict outcomes of surgical decompression. Acta Neurochir (Wien). 2020 Jun;162(6):1439-1444. doi: 10.1007/s00701-020-04344-3. Epub 2020 Apr 23.
• Lale A, Kirkil C, Ozturk S, Yur M, Can OF, Artas G, Aygen E. The results of surgical decompression in the treatment of foot drop due to peroneal nerve entrapment after bariatric surgery. Surg Obes Relat Dis. 2020 Nov;16(11):1684-1691. doi: 10.1016/j.soard.2020.06.054. Epub 2020 Jul 15.
• Wilson C, Yaacoub AP, Bakare A, Bo N, Aasar A, Barbaro NM. Peroneal nerve decompression: institutional review and meta-analysis to identify prognostic associations with favorable and unfavorable surgical outcomes. J Neurosurg Spine. 2019 Feb 8:1-8. doi: 10.3171/2018.10.SPINE18626. Online ahead of print.
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• Aprile I, Caliandro P, Foschini M, Di Stasio E, Padua L; Italian CTS and other Entrapments Study Group; Mondelli M. Multicentre study of peroneal mononeuropathy: multiperspective follow-up of nonsurgical cases. J Peripher Nerv Syst. 2007 Sep;12(3):232-3. doi: 10.1111/j.1529-8027.2007.00145.x. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Anticipated): December 31, 2027
• Study Completion (Anticipated): December 31, 2028

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Conservative treatment; Foot drop; Peroneal nerve; Neurolysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Peroneal Neuropathies
• Other Study ID Numbers: S62895; KCE19-1232 (Other Grant/Funding Number: KCE Belgium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No