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

Phase 4

Withdrawn

• Conditions: snapping finger; Stenosing tenosynovitis; 10043237; 10041297

• Registration Number: NL-OMON31447
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 490

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The treatment of Trigger Fingers will be considered to be succesful when the<br /><br>Plastic Surgeon scores 'grade 0' in accordance with the gradation of Patel and<br /><br>Moradia* to the treated Trigger Finger. Alongside should the following findings<br /><br>be absent: A1 pulley tenderness during palpation, pain during passive extension<br /><br>and tenderness along the flexor tendon on resisted isometric flexion.<br /><br><br /><br>*Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without<br /><br>cortisone injection. J Hand Surg (Am) 1997;22A:150-155</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The complications which occur after administering the corticosteroid<br /><br>injections in the treatment of adults with Trigger Fingers;<br /><br>- The complications which occur after the 'open' surgical intervention in the<br /><br>treatment of adults with Trigger Fingers;<br /><br>- The patient characteristics which are associated with a higher risk to<br /><br>develop a Trigger Finger (specific interest for patients with Diabetes<br /><br>Mellitus);<br /><br>- The efficacy, in percents, of the 'open' surgical intervention in the<br /><br>treatment of adults with Trigger Fingers when the steroid injections will not<br /><br>be successful;<br /><br>- A valid treatment protocol for adults affected with a Trigger Finger and<br /><br>adults affected with a Trigger Finger in a risk group, in which the most<br /><br>efficacy and the lowest complication risk will be found. </p><br>