Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers

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

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.

Study Overview

• Status: Recruiting
• Conditions: Trigger Finger; Stenosing Tenosynovitis
• Intervention / Treatment: Procedure: A1 pulley division; Procedure: A1 pulley division + Resection of one or both slips of the FDS tendon

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Patients could choose to be withdrawn from the study at any point.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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thierry Christen, MD; Phone Number: +41(0)795561287; Email: thierry.christen@chuv.ch

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Recruiting
      • CHUV
      • Contact: Thierry Christen, MD; Phone Number: +41(0)795561287; Email: thierry.christen@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A1 pulley group; A1 pulley division only	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.
Experimental: A1 pulley + FDS group; Combination of A1 pulley division and excision of one or both slips of the flexor digitorum superficialis tendon	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: trigger finger; stenosing flexor tenosynovitis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tenosynovitis; Trigger Finger Disorder; Tendon Entrapment
• Other Study ID Numbers: 2018-01270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No