Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers

NCT ID: NCT04675892

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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Patients could choose to be withdrawn from the study at any point.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.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A1 pulley group

A1 pulley division only

Group Type: ACTIVE_COMPARATOR

A1 pulley division

Intervention Type: PROCEDURE

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 + FDS group

Combination of A1 pulley division and excision of one or both slips of the flexor digitorum superficialis tendon

Group Type: EXPERIMENTAL

A1 pulley division + Resection of one or both slips of the FDS tendon

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Thierry Christen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHUV

Lausanne, Canton of Vaud, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Thierry Christen, MD

Role: CONTACT

thierry.christen@chuv.ch

+41(0)795561287

Facility Contacts

Thierry Christen, MD

Role: primary

thierry.christen@chuv.ch

+41(0)795561287

Other Identifiers

2018-01270

Identifier Type: -

Identifier Source: org_study_id