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The efficacy of Trigger Finger treatment: a randomised, controlled, prospective clinical multicenter trial.

The efficacy of Trigger Finger treatment: a randomised, controlled, prospective clinical multicenter trial. - Efficacy of Trigger Finger treatment

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31447
Enrollment
490
Registered
2008-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

snapping finger Stenosing tenosynovitis

Interventions

1) Apllication of maximal 2 corticosteroïd injections 2) 'open' surgical release A1 pulley

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)