|- candidate number||22541|
|- NTR Number||NTR5347|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-aug-2015|
|- Secondary IDs||NL47990.078.14 |
|- Public Title||Shock wave therapy after ankle arthrodesis |
|- Scientific Title||Extracorporeal shock wave therapy for bone regeneration in ankle arthrodeses|
|- hypothesis||We hypothesize that the chance for delayed and non-unions after ankle arthrodesis is significantly reduced when ESW are applied at the end of the surgical arthrodesis. We think that these beneficial outcomes will positively affect patient satisfaction.|
Furthermore, we hypothesize that bone regeneration is stimulated such that the standard casting period of 12 weeks can be reduced.
|- Healt Condition(s) or Problem(s) studied||Arthrodesis, Extracorporeal shock waves, Ankle, Arthrosis|
|- Inclusion criteria||- Primary ankle arthrodesis|
- 18 years or older
- good understanding of the Dutch language
- willing to participate
|- Exclusion criteria||- previous ankle arthrodesis |
- inability to walk
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2015|
|- planned closingdate||31-dec-2018|
|- Target number of participants||76|
|- Interventions||Ankle arthrodesis is performed in the usual way. At the end of the operation, when patients still have anaesthesia, ESW will or will not be applied to the ankle joint, according to randomization.|
|- Primary outcome||- Number of delayed unions at 12 weeks follow-up|
|- Secondary outcome||- Number of non-unions at 26 weeks after ankle arthrodesis|
- SF-36, FAOS and AOFAS survey scores pre-operative and at 16 and 26 weeks
|- Timepoints||pre-operative, 0, 6, 12, 16, 26 weeks|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A. Willems|
|- CONTACT for SCIENTIFIC QUERIES|| A. Willems|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Orthopaedics|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Arthrodesis of the ankle joint is a common surgical procedure in end-stage ankle osteoarthritis. Unfortunately there is a high risk for delayed unions (~40%), and to a lesser extent non-unions (~10%). Application of extracorporeal shock waves (ESW) is a very potent non-invasive therapy for bone regeneration because it stimulates early angiogenesis and subsequent osteogenesis. Therefore ESW therapy might strongly reduce the number delayed and non-unions.
Objective: The primary research question includes: Does extracorporeal shock wave therapy (ESWT) reduce the chance for delayed unions after ankle arthrodesis at 12 weeks? Secondary end-points include number of non-unions at 26 weeks, improvement of SF-36, FAOS and AOFAS questionnaires during 26 weeks follow-up. Furthermore, the amount of bony union is assessed with CAT-scans at 6 and 12 weeks.
Study design: Prospective double-blind randomized controlled trial.
Study population: Patients who will receive a primary ankle arthrodesis, are 18 years or older, speak Dutch and are willing to participate can be included in the study.
Intervention (if applicable): Ankle arthrodesis is performed in the usual way. At the end of the operation, when patients still have anaesthesia, ESW will or will not be applied to the ankle joint, according to randomization. In patients that do receive ESWT, 4000 shock waves with an Energy focused density (EFD) of 0.41 mJ/mm2 are applied
Main study parameters/endpoints: Number of delayed unions at 12 weeks follow-up.
|- Main changes (audit trail)||20-jun-2016:
- Inclusion criteria:
OLD: Primary ankle arthrodesis
NEW: Primary talocrural arthrodesis
- Exclusion criteria:
OLD: Previous ankle arthrodesis
NEW:Previous ipsilateral talocrural arthrodesis
- Secondary outcome score:
OLD: SF-36, FAOS and AOFAS survey scores pre-operative and at 16 and 26 weeks.
NEW: SF-36 and FAOS survey scores pre-operative and at 16 and 26 weeks. AOFAS survey score pre-operative and at 26 weeks.
|- RECORD||6-aug-2015 - 20-jun-2016|