Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers
Primary Purpose
Trigger Finger, Stenosing Tenosynovitis
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
A1 pulley division
A1 pulley division + Resection of one or both slips of the FDS tendon
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring trigger finger, stenosing flexor tenosynovitis
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.
Sites / Locations
- CHUVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A1 pulley group
A1 pulley + FDS group
Arm Description
A1 pulley division only
Combination of A1 pulley division and excision of one or both slips of the flexor digitorum superficialis tendon
Outcomes
Primary Outcome Measures
Change in total active finger motion in degrees
Change in preoperative and postoperative overall range of motion of the finger joints in degrees
Secondary Outcome Measures
Change in with the visual analog scale
Change in pain with the visual analog scale
Full Information
NCT ID
NCT04675892
First Posted
November 20, 2020
Last Updated
December 17, 2020
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT04675892
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Stenosing Tenosynovitis
Keywords
trigger finger, stenosing flexor tenosynovitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1 pulley group
Arm Type
Active Comparator
Arm Description
A1 pulley division only
Arm Title
A1 pulley + FDS group
Arm Type
Experimental
Arm Description
Combination of A1 pulley division and excision of one or both slips of the flexor digitorum superficialis tendon
Intervention Type
Procedure
Intervention Name(s)
A1 pulley division
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
A1 pulley division + Resection of one or both slips of the FDS tendon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total active finger motion in degrees
Description
Change in preoperative and postoperative overall range of motion of the finger joints in degrees
Time Frame
Preoperative (days to weeks prior to surgery), 4 weeks after surgery
Secondary Outcome Measure Information:
Title
Change in with the visual analog scale
Description
Change in pain with the visual analog scale
Time Frame
Preoperative (days to weeks prior to surgery), 4 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thierry Christen, MD
Phone
+41(0)795561287
Email
thierry.christen@chuv.ch
Facility Information:
Facility Name
CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry Christen, MD
Phone
+41(0)795561287
Email
thierry.christen@chuv.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Resection of Flexor Digitorum Superficialis Tendon for Severe Trigger Fingers
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