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RECRUITING
NCT04695834
NA

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2021-04-28

Completion Date

2028-12-31

Last Updated

2024-07-01

Healthy Volunteers

No

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

Locations (18)

AZ Sint-Maarten

Mechelen, Antwerpen, Belgium

AZ Turnhout

Turnhout, Antwerpen, Belgium

Sint Augustinus

Wilrijk, Antwerpen, Belgium

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

AZ Vesalius

Tongeren, Limburg, Belgium

AZ Alma

Eeklo, Oost-Vlaanderen, Belgium

AZ Sint-Lucas

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Jan

Bruges, West-Vlaanderen, Belgium

AZ Groeninge, department of neurosurgery

Kortrijk, West-Vlaanderen, Belgium

AZ Damiaan

Ostend, West-Vlaanderen, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

Universitaire Ziekenhuizen Antwerpen

Antwerp, Belgium

ULB Erasme, department of neurosurgery

Brussels, Belgium

UZ Brussel

Brussels, Belgium

Ziekenhuis Oost-Limburg, department of neurosurgery

Genk, Belgium

University Hospitals Of Leuven, department of neurosurgery

Leuven, Belgium

CHU de Liège, department of neurosurgery

Liège, Belgium

Leids Universitair Medisch Centrum, department of neurosurgery

Leiden, Netherlands