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

NCT04695834 | Recruiting DMC

• 2 other identifiers: S62895KCE19-1232
• Study Type: interventional
• Target: 182
• Locations: 2 countries
• Sites: 18

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.

Conditions

Peroneal Nerve Entrapment

Keywords

Peroneal nerve; Neurolysis; Conservative treatment; Randomised controlled trial; Foot drop

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Time to recovery

  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).

  10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))

• Ankle dorsiflexion strength as measured by isometric dynamometry.

  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

  10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))

• Complications and neurologic deficits: Sensory changes

  10 days (surgery), 6 weeks, 3 months, 6 months, 9 months and 18 months (after randomization))

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

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

Surgical treatment

ACTIVE COMPARATOR

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

Interventions

Neurolysis peroneal nerve PROCEDURE

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

Surgical treatment

Maximal physiotherapy OTHER

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

Conservative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, …).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Belgian Health Care Knowledge Centre (KCE): collaborator

Study Sites (18)

AZ Sint-Maarten

Mechelen, Antwerpen, 2800, Belgium

NOT YET RECRUITING

AZ Turnhout

Turnhout, Antwerpen, 2300, Belgium

NOT YET RECRUITING

Sint Augustinus

Wilrijk, Antwerpen, 2610, Belgium

NOT YET RECRUITING

Jessa Ziekenhuis

Hasselt, Limburg, 3500, Belgium

NOT YET RECRUITING

AZ Vesalius

Tongeren, Limburg, 3717, Belgium

NOT YET RECRUITING

AZ Alma

Eeklo, Oost-Vlaanderen, 9900, Belgium

NOT YET RECRUITING

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

NOT YET RECRUITING

AZ Groeninge, department of neurosurgery

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

AZ Damiaan

Ostend, West-Vlaanderen, 8400, Belgium

NOT YET RECRUITING

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

NOT YET RECRUITING

Universitaire Ziekenhuizen Antwerpen

Antwerp, 2000, Belgium

NOT YET RECRUITING

ULB Erasme, department of neurosurgery

Brussels, 1000, Belgium

RECRUITING

UZ Brussel

Brussels, 1000, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg, department of neurosurgery

Genk, 3600, Belgium

RECRUITING

University Hospitals Of Leuven, department of neurosurgery

Leuven, 3000, Belgium

RECRUITING

CHU de Liège, department of neurosurgery

Liège, 4000, Belgium

RECRUITING

Leids Universitair Medisch Centrum, department of neurosurgery

Leiden, 2333, Netherlands

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Tom Theys, M.D.; Ph.D.

  Univeristy hospitals of Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe Oosterbos, M.D.

CONTACT

+3216344290; christopheoosterbos@gmail.com

Tom Theys, M.D.; Ph.D.

CONTACT

+3216344290; tom.theys@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All participants will be asked to wear long trousers to cover a potential scar at the level of the knee. All patients will be asked to apply a bandage at the site of the operation (or the site of entrapment if there was no operation) Participants are not allowed to discuss their treatment with the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Multi-center Randomized Parallel-group

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 5, 2021
• Study Start: April 28, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); BE (17)