Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers

NCT04675892 | Recruiting

• 1 other identifier: 2018-01270
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Keywords

trigger finger; stenosing flexor tenosynovitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in with the visual analog scale

  Preoperative (days to weeks prior to surgery), 4 weeks after surgery

Study Arms (2)

A1 pulley group

ACTIVE COMPARATOR

A1 pulley division only

Procedure: A1 pulley division

A1 pulley + FDS group

EXPERIMENTAL

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

Interventions

A1 pulley division 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 group

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

A1 pulley + FDS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Trigger Finger Disorder; Tendon Entrapment

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Thierry Christen, MD

CONTACT

+41(0)795561287; thierry.christen@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 19, 2020
• Study Start: November 1, 2018
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)