Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers

Trigger Finger Clinical Trial

Official title:

Resection of One or Both Slips of the Flexor Digitorum Superficialis Tendon for Cases of Severe Trigger Fingers. A Randomized Prospective Single Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675892
• Other study ID #: 2018-01270
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Thierry Christen, MD
• Phone: +41(0)795561287
• Email: thierry.christen[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of resection of one or both slips of the flexor digitorum superficialis tendon versus the A1 pulley division.

Description:

The preoperative visit occurred a number of weeks or months prior to surgery. Surgeons from the Centre de la main at the CHUV in Lausanne recruited the subjects during their consultations. During this initial visit, the patient was asked about his problem, his general health and a clinical examination (including range of motion of finger joints, pulp-to-palm distance, pain evaluated with a VAS) was performed. Once the diagnosis of trigger finger was established, the inclusion and exclusion criteria were evaluated. If the eligibility criteria were fulfilled, the patients were offered to be part of the study. They received oral and written information about the study and the surgeons gave further explanation if needed.

On the surgery day, the signed consent form was recovered. Participants were randomized in two groups according to a computer-generated list ranging from 01 to 60 (www.randomization.com). Surgery was then performed according to the method chosen by randomization. The possible occurrence of adverse effects during surgery was monitored. All information was recorded on the case report forms.

The first postoperative visit occurred 1 week ± 3 days after surgery. The surgeons evaluated the wound to exclude the presence of postoperative complication (infection, hematoma, nerve or tendon injury) and answer any question the patient could have. Range of motion and pain were recorded. All information was recorded on the case report forms.

The second postoperative visit occurred 4 weeks ± 5 days after surgery. The appointment was conducted in the same way as the previous one.

Patients could choose to be withdrawn from the study at any point. The follow-up was similar to that of patients included in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (=18 years old) with a flexor tendon tenosynovitis of a finger resulting in a decreased range of motion of the PIP joint (defined with a palm-to-pulp distance =0mm and/or flexion contracture =15°).

Exclusion Criteria:

• Minors (<18 years old).

• PIP joint contracture resulting from another illness than stenosing flexor tenosynovitis (for example: rheumatoid arthritis) or caused by a traumatic event.

• Contraindications to any surgery: presence of a severe coagulation disorder, immunosuppression or decompensated psychiatric illness.

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis
• Trigger Finger
• Trigger Finger Disorder

Intervention

Procedure:
• A1 pulley division
Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %). Division of the A1 pulley. Wound closure with absorbable sutures and application of a light dressing.
• A1 pulley division + Resection of one or both slips of the FDS tendon
Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %). Division of the A1 pulley. Palmar Bruner incision over the PIP joint. Distal dissection and resection of one or both slips of the FDS tendon. Wound closure with absorbable sutures and application of a light dressing.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total active finger motion in degrees	Change in preoperative and postoperative overall range of motion of the finger joints in degrees	Preoperative (days to weeks prior to surgery), 4 weeks after surgery
Secondary	Change in with the visual analog scale	Change in pain with the visual analog scale	Preoperative (days to weeks prior to surgery), 4 weeks after surgery