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…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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
- The complications which occur after administering the corticosteroid
injections in the treatment of adults with Trigger Fingers;
- The complications which occur after the 'open' surgical intervention in the
treatment of adults with Trigger Fingers;
- The patient characteristics which are associated with a higher risk to
develop a Trigger Finger (specific interest for patients with Diabetes
Mellitus);
- 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;
- 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.
Background 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.
Study objective
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.
Study design
Randomised, controlled, prospective, clinical multi-centre trial.
Intervention
1) Apllication of maximal 2 corticosteroïd injections
2) 'open' surgical release A1 pulley
Study burden and risks
The sequence of first injecting after which, in case of an unsatisfactory
result will be proceeded to the surgical treatment is preserved in the greater
part of the Dutch hospitals.
Up to now there aren't any adverse or serious adverse events reported from
either of both treatments which will be investigated.
The extra burden for contestants regarding to not-contestants will be filling
in minimal three and maximal five questionnaires which will take an average of
ten minutes. We do not expect considerable psychological or physical burden for
contestants in comparison with not-contestants.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
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
- Incapacitated patients;
- Patients less then 18 years of age;
- Women who would like to become pregnant during the period of the trial;
- Pregnant women;
- Lactating women.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001315-38-NL |
| CCMO | NL19294.041.07 |