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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04675892
Other study ID # 2018-01270
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date December 1, 2024

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire Vaudois
Contact Thierry Christen, MD
Phone +41(0)795561287
Email thierry.christen@chuv.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 Patients could choose to be withdrawn from the study at any point.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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Switzerland CHUV Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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