Clinical trial NCT04675892: Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trigger Finger
Stenosing Tenosynovitis
Keywords: trigger finger
stenosing flexor tenosynovitis
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in total active finger motion in degrees
timeFrame: Preoperative (days to weeks prior to surgery), 4 weeks after surgery
Secondary outcomes:
measure: Change in with the visual analog scale
timeFrame: Preoperative (days to weeks prior to surgery), 4 weeks after surgery
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
Study officials:
References: