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

NCT ID: NCT06747962

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2027-01-31

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.

Conditions

Trigger Digit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pull out tenolysis group

A1 pulley release and pull out tenolysis for the treatment of trigger fingers and thumb

Group Type: ACTIVE_COMPARATOR

A1 pulley release and pull out tenolysis

Intervention Type: PROCEDURE

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.

Simple A1 pulley release group

Simple A1 pulley release for the treatment of trigger fingers and thumb

Group Type: PLACEBO_COMPARATOR

Simple A1 pulley release

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eleni Karagergou

OTHER

Sponsor Role: lead

Responsible Party

Eleni Karagergou

Consultant Plastic and Hand Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Panagiotis Givissis, Professor

Role: STUDY_CHAIR

Aristotle University Of Thessaloniki

Locations

Aristotle University of Thessaloniki, 1st Orthopaedic Department, G. Papanikolaou Hospital

Thessaloniki, Thessaloniki, Greece

Countries

Greece

Central Contacts

Eleni Karagergou, MD, PhD

Role: CONTACT

krgeleni@gmail.com

+306972386716

Dimitrios Kitridis, MD

Role: CONTACT

dkitridis@gmail.com

Facility Contacts

Panagiotis Givissis, Professor, Head of Orthopaedic

Role: primary

orthopaedikipapanikolaou@gmail.com

+302313307681

Panagiotis Givissis, Professor

Role: backup

Eleni Karagergou, MD, PhD

Role: backup

Dimitrios Kitridis, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 24156581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30054030 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31438789 (View on PubMed)

Other Identifiers

1543/ 18.11.2024

Identifier Type: -

Identifier Source: org_study_id