Zusammenfassung (Niederländisch oder Französisch oder Englisch)
TRIAL DESCRIPTION
| Title | A prospective, multi-center, randomized, parallel-group controlled trial to compare conservative versus surgical treatment of foot drop in peroneal nerve entrapment – Foot Drop |
| Participants (P) | Patients with electrodiagnostic (EDX)-documented peroneal nerve entrapment with persisting foot drop 10 +/- 4 weeks after onset of symptoms will be included in the trial. Imaging to exclude a compressive mass at the level of the fibular head is required, since these patients are excluded from the trial. |
| Intervention (I) | Decompressive release of the peroneal nerve at the level of the fibular head |
| Control (C) | Maximal (prolonged) conservative treatment with physiotherapy aiming at muscle strengthening and gait rehabilitation. Allowed: use of foot-ankle orthosis / electrostimulation and other therapies reflecting daily practice |
| Outcome (O) | Difference in distance (in meters) covered during the six-minute walk test between baseline and 9 months after randomization |
| Trial Design | This is a prospective, multi-center, randomized, parallel-design study. This is a superiority trial: the goal is to prove superiority of surgery to maximal conservative treatment. Subjects will be randomized 1:1 to surgery or to conservative treatment. No cross-over is allowed until the primary endpoint is assessed at 9 months after randomization. After the primary endpoint is assessed, cross-over to surgery is allowed, with extended follow-up at 18 months after randomization (equals 9 months after primary endpoint). |
| Sample Size | Overall, the study will enrol 182 subjects in 2 treatment arms, 91 subjects per arm. The statistical analysis plan will contain a blinded sample size reassessment to verify if the planned sample size is sufficient to show the minimal clinical important difference. |
| Trial duration | 69 months |
| Budget | €2.14 MIO |
TRIAL TEAM
| Sponsor | UZ Leuven |
| Chief Investigator | Prof. Dr. Tom Theys |
| Participating sites and Investigators | 26 with 2 in NL (full study) |
| External partner | none |
DOCUMENTS
| Protocol | Download protocol View publication Trials |
| Results | View publication (pilot study) (Pilot and Feasibility studies) |
| Extra Info | Download Information for patients (FR) Download Information for patients (NL) |
For timelines and recruitment, see dashboard
REFERENCES
FUNDING SCHEME
2019 Investigator led
