|- candidate number||17690|
|- NTR Number||NTR4584|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2014|
|- Secondary IDs||1401 METC Maxima MC|
|- Public Title||Wel of geen K-draad plaatsen bij een hamerteencorrectie?|
|- Scientific Title||Fixed hammertoe correction, with or without K-wire fixation?|
|- hypothesis||It is hypothesized that both surgical techniques do not make more than 10 points difference in the American Orthopaedic Foot and Ankle Society (AOFAS) lesser toe metatarsophalangeal scale, one year after surgery. |
|- Healt Condition(s) or Problem(s) studied||Hamertoe, Surgery, Surgical correction|
|- Inclusion criteria||Patients older than 18 years, diagnosed with hammer toe 2nd, 3rd, or 4th toe.|
|- Exclusion criteria||Other current foot problem at the same foot. |
Other foot surgery should be performed in the same session.
Patients with invalidating rheumatoid arthritis.
Patients with insulin depending diabetes mellitus.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2014|
|- planned closingdate||1-jun-2017|
|- Target number of participants||46|
|- Interventions||Dorsal incision over the deformed PIP joint, cleavage of the extensor tendon, opening and release of the joint capsule, resection of the distal condyles of the proximal phalanx, resection of the sharp edges of the bone, wound irrigation with NaCl, verification of position, randomization for group A or B.
A. Placement of the K-wire inside out, outside in through the distal, mid and proximal phalanx. Wound closure with Donati sutures of monocryl.
B. Wound closure with Donati sutures of monocryl.
Continuous pressure bandage for 7 days, and weight bearing as tolerated in a special shoe for 4 weeks.
|- Primary outcome||AOFAS lesser toe metatarsophalangeal scale one year after surgery. |
|- Secondary outcome||AOFAS lesser toe metatarsophalangeal scale score after 6 weeks.|
Complications between the two techniques:
- infection (combination of new or increasing pain, erythema, local warmth and swelling and/or purulent discharge)
- deep venous thrombosis of the ipsilateral leg (diagnosed by ultrasound)
- vascular problems (necrosis of the skin of the toe 2,4,6 weeks or 1 year after the operation)
Toe position one year after surgery (Part of the AOFAS lesser toe metatarsophalangeal scale)
Requirement for revision surgery e.g as indicated by infection or malalagniment.
|- Timepoints||baseline (preoperative) |
6 weeks, and 1 year
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.G.E. Hendriks|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.G.E. Hendriks|
|- Sponsor/Initiator ||Máxima Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-mei-2014 - 5-jun-2014|