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.
ID
Bron
Verkorte titel
Aandoening
1. Trigger Finger;
2. Stenosing tenosynovitis;
3. Corticosteroid injection;
4. 'open' surgical intervention;
(NLD: Trigger Finger, Stenosing tenosynovitis, Corticosteroïd injectie, 'open' chirurgische ingreep).
Ondersteuning
Secretariaat Plastische Chirurgie UMC Utrecht
kamer G04.122
Postbus 85500
3508 GA Utrecht
E-mail: Eva_Esschendal@hotmail.com
Tel: +31 30 250 6954
Fax: +31 30 251 6097
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.<br>
<br><br>
*Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg (Am) 1997;22A:150-155.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
A.S.E. Esschendal
Secretariaat Plastische Chirurgie UMC Utrecht
kamer G04.122
Utrecht
The Netherlands
+31 30 250 6954
Eva_Esschendal@hotmail.com
Wetenschappelijk
A.S.E. Esschendal
Secretariaat Plastische Chirurgie UMC Utrecht
kamer G04.122
Utrecht
The Netherlands
+31 30 250 6954
Eva_Esschendal@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1100 |
NTR-old | NTR1135 |
CCMO | NL31078.068.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
OMON | NL-OMON36372 |