Clinical trial NCT06747962: Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Digits
Official title: A1 Pulley Release and Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Fingers and Thumb. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trigger Digit
Keywords: trigger finger
trigger thumb
traction tenolysis
pull-out tenolysis
A1 pulley
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trigger finger is a common tendinopathy and clinically presents with painful catching or popping as the patient flexes and extends the digit, due to mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal at the level of the metacarpal head. If conservative management with corticosteroid injection and splinting fails or if symptoms recur, surgery and division of the A1 pulley are indicated. Traction (or pull- out) tenolysis is a maneuver based on pulling of the flexor tendons out of the wound, to release any adhesions that might have occurred due to long- standing triggering. Although it has been associated with postoperative pain and stiffness, no robust evidence exists to support its benefit or not. In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull- out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull-out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended.

Detailed description: Trigger finger is a common condition that can cause hand pain and disability. It involves entrapment of the flexor tendons of the fingers and thumb within their flexor tendon sheath at the level of the metacarpal head. This phenomenon is due to the mechanical impingement of the thickened flexor tendons as they pass through a narrow tendon sheath canal. It can cause painful catching or popping as the patient flexes and extends the digit. On occasion, the digit will lock in flexion and require passive manipulation to extend. Initial management can be conservative with corticosteroid injection and splinting. If conservative management fails or if symptoms recur, surgical release of the A1 pulley is indicated. This is a common procedure which is performed under local anaesthesia. Intraoperatively, following division of A1 pulley, a traction tenolysis is occasionally performed by some surgeons. This maneuver, which is based on pulling of the flexor tendons out of the wound, is believed to release any adhesions that might have occurred due to long- standing triggering but it has been reported to result in prolonged postoperative pain and stiffness. However, there is no robust evidence to support a less favorable outcome following traction tenolysis. Aim of the study: In view of the low quality evidence regarding the pros and cons of traction (or pull-out) tenolysis following A1 pulley release, the investigators will compare simple A1 pulley release versus A1 pulley release and pull-out tenolysis in a prospective randomized study design. Hypothesis of the study is that the pull-out tenolysis yields better results in terms of total active range of movement, pinch and grip strength, pain and quick-DASH scoring when compared to simple pulley release. The confirmation of the hypothesis will justify the use of pull-out tenolysis as a means of breaking any tendon adhesions and returning to normal function sooner. On the contrary, if the pull- out tenolysis is linked to a less favorable functional outcome, simple A1 pulley release will be recommended. The study will be conducted in accordance with the Declaration of Helsinki and the Guidelines on Good Clinical Practice.

Eligibility criteria: Inclusion Criteria:

* Patients with single trigger finger that failed conservative treatment
* Patients with single trigger finger that had recurrence of symptoms after conservative treatment

Exclusion Criteria:

* Patients with limited range of movement before appearance of triggering
* Patients with osteoarthritis / rheumatoid arthritis
* Patients that had a second procedure at the same time of trigger finger release (eg carpal tunnel release).

Primary outcomes:
measure: Total active range of motion (AROM) of the affected finger
timeFrame: 2 weeks
measure: Total active range of motion (AROM) of the affected finger
timeFrame: 6 weeks
measure: Total active range of motion (AROM) of the affected finger
timeFrame: 3 months
measure: Visual Analog Scale (VAS) for pain relief
timeFrame: 2 weeks
measure: Visual Analog Scale (VAS) for pain relief
timeFrame: 6 weeks
measure: Visual Analog Scale (VAS) for pain relief
timeFrame: 3 months
Secondary outcomes:
measure: Grip and Pinch strength
timeFrame: 6 weeks
measure: Grip and Pinch strength
timeFrame: 3 months
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
timeFrame: 6 weeks
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score
timeFrame: 3 months
Other outcomes:
measure: Rate of complications
timeFrame: Up to 3 months postoperatively
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki, 1st Orthopaedic Department, G. Papanikolaou Hospital
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Panagiotis Givissis, Professor
role: STUDY_CHAIR
References:
citation: Choudhury MM, Tay SC. Outcome of traction tenolysis in open trigger finger release--a retrospective review. Hand Surg. 2013;18(3):375-9. doi: 10.1142/S0218810413500421.
citation: Baek JH, Chung DW, Lee JH. Factors Causing Prolonged Postoperative Symptoms Despite Absence of Complications After A1 Pulley Release for Trigger Finger. J Hand Surg Am. 2019 Apr;44(4):338.e1-338.e6. doi: 10.1016/j.jhsa.2018.06.023. Epub 2018 Jul 25.
citation: Yang TC, Fufa D, Huang HK, Huang YC, Chang MC, Wang JP. Percutaneous A1 Pulley Release Combined with Finger Splint for Trigger Finger with Proximal Interphalangeal Joint Flexion Contracture. J Hand Surg Asian Pac Vol. 2019 Sep;24(3):270-275. doi: 10.1142/S2424835519500334.