|- candidate number||2892|
|- NTR Number||NTR1135|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-nov-2007|
|- Secondary IDs||NL310783TF07 |
|- Public Title||The efficacy of Trigger Finger treatment: a randomised, controlled, prospective clinical multicenter trial. |
|- Scientific Title||The efficacy of Trigger Finger treatment: a randomised, controlled, prospective clinical multicenter trial. |
|- hypothesis||We suspect that Trigger Finger treatment by corticosteroid injections will approach the efficiacy which is reached by the 'open' surgical intervention: surgical release of the A1 pulley.|
|- Healt Condition(s) or Problem(s) studied||Trigger finger|
|- Inclusion criteria||Capacitated adults to which a treatment for their Trigger Finger will be advised at the outpatient clinic of the plastic surgery in the UMC Utrecht, The Hand Clinic Amsterdam, Diakonessenhuis Zeist, the Mesos Medical Center Utrecht, the St. Antonius Hospital Nieuwegein, the Zuwe Hofpoort Hospital Woerden and the Meander Medical Center Amersfoort. |
|- Exclusion criteria||1. Incapacitated patients;|
2. Patients less then 18 years of age;
3. Women who would like to become pregnant during the period of the trial;
4. Pregnant women;
5. Lactating women.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2008|
|- planned closingdate||1-jan-2011|
|- Target number of participants||490|
|- Interventions||1. Up to two injections triamcinolone acetonide A-10 with six weeks interval between each injection in the A1 pulley of the Trigger Finger;|
2. 'open' surgical intervention: surgical release of the A1 pulley of the Trigger Finger.
|- Primary outcome||The treatment of Trigger Fingers will be considered to be succesful when the Plastic Surgeon scores 'grade 0' in accordance with the gradation of Patel and Moradia* to the treated Trigger Finger. Alongside should the following findings be absent: A1 pulley tenderness during palpation, pain during passive extension and tenderness along the flexor tendon on resisted isometric flexion.|
*Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg (Am) 1997;22A:150-155.
|- Secondary outcome||1. The complications which occur after administering the corticosteroid injections in the treatment of adults with Trigger Fingers; |
2. The complications which occur after the 'open' surgical intervention in the treatment of adults with Trigger Fingers;
3. The patient characteristics which are associated with a higher risk to develop a Trigger Finger (specific interest for patients with Diabetes Mellitus);
4. The efficacy, in percents, of the 'open' surgical intervention in the treatment of adults with Trigger Fingers when the steroid injections will not be successful;
5. A valid treatment protocol for adults affected with a Trigger Finger and adults affected with a Trigger Finger in a risk group, in which the most efficacy and the lowest complication risk will be found.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| A.S.E. Esschendal|
|- CONTACT for SCIENTIFIC QUERIES|| A.S.E. Esschendal|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Several factors can cause a Trigger Finger. There are two accepted treatments for the Trigger Finger nowadays: corticosteroid injections in the affected tendon sheath and surgical release of the affected tendon sheath under local anaesthesia.
It is known that the surgical release is effective, although in comparison with corticosteroid injections it is thorough, expensive and it has higher complication rate.
In this moment there isn't a reliable trial available to determine the effectiveness of corticosteroid injections for the treatment of Trigger Fingers. The very diverse relapse chances after steroidinjections, known from the mostly retrospective trials, are used as an argument to perform a primary surgical treatment.
We would like to investigate the efficiacy of the treatment of Trigger Fingers by means of a reliable, randomised, controlled, prospective multi-center trial at a large-scale with a long term follow-up.
After completion of the trial we will be able to report on the efficiacy of the 'open' surgical treatment as well as the efficiacy of steroidinjections. We will use this result to create a Trigger Finger protocol taking the efficiacy, co-morbidity and costs aspects in account.|
|- Main changes (audit trail)|
|- RECORD||18-nov-2007 - 3-apr-2008|