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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Jan 4, 2021

Keywords

ClinConnect Summary

The FOOT DROP trial is studying whether surgery to relieve pressure on the peroneal nerve is more effective than the best non-surgical treatment for patients who have ongoing foot drop, a condition that makes it difficult to lift the front part of the foot. This trial is specifically for adults aged 18 and older who have had foot drop for about 10 weeks and have been diagnosed with peroneal nerve entrapment through specific testing. Participants will be randomly assigned to either the surgical group or the group that receives conservative treatment, which includes physical therapy and other non-invasive options.

If you join the trial, you will be asked to complete several questionnaires and undergo tests to measure muscle strength and walking ability over 9 months. The main goal is to see how far you can walk in six minutes after the treatment compared to your starting point. It's important to note that certain conditions, like previous injuries to the nerve or other health issues that could affect your walking, may prevent you from participating. This trial is currently recruiting participants, so if you think you might be eligible, you can reach out to learn more.

Gender

ALL

Eligibility criteria

• 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, ...).