Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Digits

A1 Pulley Release and Pull-out Tenolysis Versus Simple A1 Pulley Release in Trigger Fingers and Thumb. a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trigger Digit
• Intervention / Treatment: Procedure: A1 pulley release and pull out tenolysis; Procedure: Simple A1 pulley release

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eleni Karagergou, MD, PhD; Phone Number: +306972386716; Email: krgeleni@gmail.com
• Study Contact Backup: Name: Dimitrios Kitridis, MD; Email: dkitridis@gmail.com

Study Locations

• Greece
  • Thessaloniki, Greece, 57010
    • Aristotle University of Thessaloniki, 1st Orthopaedic Department, G. Papanikolaou Hospital
    • Contact: Panagiotis Givissis, Professor, Head of Orthopaedic; Phone Number: +302313307681; Email: orthopaedikipapanikolaou@gmail.com
    • Contact: Panagiotis Givissis, Professor
    • Contact: Eleni Karagergou, MD, PhD
    • Contact: Dimitrios Kitridis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pull out tenolysis group; A1 pulley release and pull out tenolysis for the treatment of trigger fingers and thumb	Procedure: A1 pulley release and pull out tenolysis; A short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley under direct vision. Flexor digitorum superficialis and flexor digitorum profundus tendons or flexor pollicis longus tendon (for the thumb) will be gently pulled out of the wound with two mosquito forceps to break any adhesions. The wound will be closed primarily with sutures. The patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures.
Placebo Comparator: Simple A1 pulley release group; Simple A1 pulley release for the treatment of trigger fingers and thumb	Procedure: Simple A1 pulley release; A short transverse incision will be made over the proximal or distal palmar crease, according to the digit involved. Blunt dissection will be used to spread the subcutaneous tissue and the palmar fascia to expose the A1 pulley. The digital nerves and vessels will be retracted and protected. The proximal edge of the A1 pulley will be identified and a scalpel blade will be used to divide the entire A1 pulley vision. After release, the patient will be asked to actively move the digit to confirm complete relief of triggering.The wound will be closed primarily with sutures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total active range of motion (AROM) of the affected finger	Comparison of total (AROM) between the groups. Measurements will be done with a goniometer	2 weeks
Total active range of motion (AROM) of the affected finger	Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.	6 weeks
Total active range of motion (AROM) of the affected finger	Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.	3 months
Visual Analog Scale (VAS) for pain relief	Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome	2 weeks
Visual Analog Scale (VAS) for pain relief	Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome	6 weeks
Visual Analog Scale (VAS) for pain relief	Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip and Pinch strength	Comparison of grip and pinch strength between the groups, as measured by a dynamometer	6 weeks
Grip and Pinch strength	Comparison of grip and pinch strength between the groups, as measured by a dynamometer	3 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score	Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.	6 weeks
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score	Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications	All complications, such as swelling, wound dehiscence and infection, will be documented and rates will be compared between the groups	Up to 3 months postoperatively

Collaborators and Investigators

• Sponsor: Eleni Karagergou
• Investigators: Study Chair: Panagiotis Givissis, Professor, Aristotle University of Thessaloniki

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: trigger finger; trigger thumb; traction tenolysis; pull-out tenolysis; A1 pulley
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder
• Other Study ID Numbers: 1543/ 18.11.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No