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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04675892
Enrollment
60
Registered
2020-12-19
Start date
2018-11-01
Completion date
2026-01-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stenosing Tenosynovitis, Trigger Finger

Keywords

trigger finger, stenosing flexor tenosynovitis

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.

Interventions

PROCEDUREA1 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.

PROCEDUREA1 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.

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in total active finger motion in degreesPreoperative (days to weeks prior to surgery), 4 weeks after surgeryChange in preoperative and postoperative overall range of motion of the finger joints in degrees

Secondary

MeasureTime frameDescription
Change in with the visual analog scalePreoperative (days to weeks prior to surgery), 4 weeks after surgeryChange in pain with the visual analog scale

Countries

Switzerland

Contacts

Primary ContactThierry Christen, MD
thierry.christen@chuv.ch+41(0)795561287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026