MedTrace Logo

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

NCT04695834 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-07-01

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Belgian Health Care Knowledge Centre (KCE)

    collaborator UNKNOWN

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Tom Theys, M.D.; Ph.D. · Univeristy hospitals of Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695834 on ClinicalTrials.gov