|- candidate number||22177|
|- NTR Number||NTR5213|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2015|
|- Secondary IDs|| 15-T-55 METC Atrium-Orbis-Zuyd|
|- Public Title||Lange termijn resultaten van de Scarf en Chevron correctie osteotomie voor de correctie van Hallux Valgus. Een
prospectief, gerandomiseerd onderzoek met meer dan 12 jaar opvolging.|
|- Scientific Title||Long-term results of the Scarf and Chevron Osteotomy for the correction of Hallux Valgus.|
A Prospective, randomized trial with more than 12 year follow up.
|- ACRONYM||Hallux valgus, Scarf, Chevron, RCT, lng term follow up|
|- hypothesis||We hypothesize that there is no difference in survival, clinical and radiological follow-up after >12 years of follow-up between the scarf and chevron osteotomy.|
|- Healt Condition(s) or Problem(s) studied||Hallux valgus, Chevron osteotomy, Scarf|
|- Inclusion criteria||o Participated in previous RCT by Deenik et al (2007).
|- Exclusion criteria||o Patients who developed systemic joint disease, e.g. rheumatoid arthritis.|
o Psychiatric patients.
o Patients who donít want to contribute to this follow-up.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2015|
|- planned closingdate||31-jul-2015|
|- Target number of participants||100|
|- Interventions||Hallux valgus correction: Chevron vs. Scarf
|- Primary outcome||The primary endpoint will be the recurrence rate of hallux valgus and reoperation rate of the same toe for hallux valgus. |
|- Secondary outcome||Comparing the initial results from the study with the long-term results between the scarf and chevron osteotomy.
The secondary endpoints will be the results from the SF-36, Kitaoka /AOFAS rating system, MOXFQ and radiographic measurements IMA and HVA. The IMA is measured as the angle between the line of the first metatarsal and the line bisecting the diaphyseal portions of the second metatarsal. The HVA is measured as the angle between the line from the center of the metatarsal base to the center of the first metatarsal head and the line connecting the midpoints of the proximal and distal articular surfaces of the proximal phalanx.
|- Timepoints||Pre-, 3, 12, 27 months and >12 years post operative.|
|- Trial web site||NA|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. M.G.M. Schotanus|
|- CONTACT for SCIENTIFIC QUERIES||Drs. M.G.M. Schotanus|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Publications||Deenik et al (2007). Scarf versus chevron osteotomy in hallux valgus: a randomized controlled trial in 96 patients. Foot Ankle Int. |
Jeuken, Ralph M., et al. "Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction." Foot & Ankle International (2016): 1071100716639574.
|- Brief summary||In 2007 Deenik et al published a randomized controlled trial comparing the scarf versus the chevron osteotomy in the treatment of hallux valgus. There were no significant differences after 27 months of follow up. Due to more technical demands of the scarf osteotomy the authors concluded that the chevron osteotomy was the first choice in the treatment of hallux valgus.
The study of Deenik was conducted in the Maasland Hospital, today known as Atrium-Orbis Medical Centre. Since then no other studies have been performed comparing these widely used operative techniques. The aim of this follow-up study is to compare the status of the hallux valgus of these same patients after more than 12 years of follow-up. We will use the same questionnaires and radiographic measurements as the original study as well as the Manchester-Oxford Foot Questionnaire (12-item MOXFQ). The aim of this study is to determine the long-term effects of both operative techniques. |
|- Main changes (audit trail)|
|- RECORD||7-mei-2015 - 22-mei-2016|