Actively Recruiting
Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01
182
Participants Needed
18
Research Sites
400 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
B
Belgian Health Care Knowledge Centre (KCE)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Follow-up and Outcome of Operative Treatment With Decompressive Release Of The Peroneal Nerve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given before any study procedures
- Confirmed peroneal nerve entrapment with foot drop persisting 10 +/- 4 weeks (MRC score 64 3)
- Imaging done (ultrasound or MRI) to exclude compressive mass
- Age 18 years or older
You will not qualify if you...
- Posttraumatic or surgery-related peroneal nerve injury
- Peroneal neuropathy caused by a compressive mass like cyst or tumor
- Nerve entrapment at sites other than the fibular head
- Mental or physical issues preventing physiotherapy participation
- Psychiatric illness
- Pregnancy
- Planned migration outside the country within 1 year after randomization
- Previous foot drop
- Permanently bedridden
- Neurological or musculoskeletal history affecting foot drop or gait assessment (e.g. polyneuropathy, hereditary neuropathy, stroke, ankle surgery)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
AZ Sint-Maarten
Mechelen, Antwerpen, Belgium, 2800
Not Yet Recruiting
2
AZ Turnhout
Turnhout, Antwerpen, Belgium, 2300
Not Yet Recruiting
3
Sint Augustinus
Wilrijk, Antwerpen, Belgium, 2610
Not Yet Recruiting
4
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
Not Yet Recruiting
5
AZ Vesalius
Tongeren, Limburg, Belgium, 3717
Not Yet Recruiting
6
AZ Alma
Eeklo, Oost-Vlaanderen, Belgium, 9900
Not Yet Recruiting
7
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium, 9000
Not Yet Recruiting
8
AZ Sint-Jan
Bruges, West-Vlaanderen, Belgium, 8000
Not Yet Recruiting
9
AZ Groeninge, department of neurosurgery
Kortrijk, West-Vlaanderen, Belgium, 8500
Actively Recruiting
10
AZ Damiaan
Ostend, West-Vlaanderen, Belgium, 8400
Not Yet Recruiting
11
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Not Yet Recruiting
12
Universitaire Ziekenhuizen Antwerpen
Antwerp, Belgium, 2000
Not Yet Recruiting
13
ULB Erasme, department of neurosurgery
Brussels, Belgium, 1000
Actively Recruiting
14
UZ Brussel
Brussels, Belgium, 1000
Not Yet Recruiting
15
Ziekenhuis Oost-Limburg, department of neurosurgery
Genk, Belgium, 3600
Actively Recruiting
16
University Hospitals Of Leuven, department of neurosurgery
Leuven, Belgium, 3000
Actively Recruiting
17
CHU de Liège, department of neurosurgery
Liège, Belgium, 4000
Actively Recruiting
18
Leids Universitair Medisch Centrum, department of neurosurgery
Leiden, Netherlands, 2333
Actively Recruiting
Research Team
C
Christophe Oosterbos, M.D.
CONTACT
T
Tom Theys, M.D.; Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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