Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers

• ClinicalTrials.gov Identifier: NCT04675892
• Recruitment Status: Recruiting
• First Posted: December 19, 2020
• Last Update Posted: February 20, 2024
• Sponsor: Centre Hospitalier Universitaire Vaudois
• Information provided by (Responsible Party): Thierry Christen, Centre Hospitalier Universitaire Vaudois

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Trigger Finger; Stenosing Tenosynovitis	Procedure: A1 pulley division; Procedure: A1 pulley division + Resection of one or both slips of the FDS tendon	Not Applicable

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Patients could choose to be withdrawn from the study at any point.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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 1, 2018
• Estimated Primary Completion Date: November 1, 2024
• Estimated Study Completion Date: December 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in total active finger motion in degrees [ Time Frame: Preoperative (days to weeks prior to surgery), 4 weeks after surgery ]
   Change in preoperative and postoperative overall range of motion of the finger joints in degrees

Secondary Outcome Measures :

1. Change in with the visual analog scale [ Time Frame: Preoperative (days to weeks prior to surgery), 4 weeks after surgery ]
   Change in pain with the visual analog scale

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Thierry Christen, MD; +41(0)795561287; thierry.christen@chuv.ch

Locations

Switzerland

CHUV; Recruiting

Lausanne, VD, Switzerland, 1011

Contact: Thierry Christen, MD +41(0)795561287 thierry.christen@chuv.ch

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

More Information

• Responsible Party: Thierry Christen, Principal investigator, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT04675892
• Other Study ID Numbers: 2018-01270
• First Posted: December 19, 2020
• Last Update Posted: February 20, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thierry Christen, Centre Hospitalier Universitaire Vaudois:

trigger finger; stenosing flexor tenosynovitis

Additional relevant MeSH terms:

Trigger Finger Disorder; Tenosynovitis; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases