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

NCT06747962 | Not Yet Recruiting

• 1 other identifier: 1543/ 18.11.2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Digit

Keywords

trigger finger; trigger thumb; traction tenolysis; pull-out tenolysis; A1 pulley

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Grip and Pinch strength

  6 weeks

• Grip and Pinch strength

  3 months

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score

  6 weeks

• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) functional score

  3 months

Other Outcomes (1)

• Rate of complications

  Up to 3 months postoperatively

Study Arms (2)

Pull out tenolysis group

ACTIVE COMPARATOR

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

Procedure: A1 pulley release and pull out tenolysis

Simple A1 pulley release group

PLACEBO COMPARATOR

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

Procedure: Simple A1 pulley release

Interventions

A1 pulley release and pull out tenolysis 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.

Pull out tenolysis group

Simple A1 pulley release 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.

Simple A1 pulley release group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eleni Karagergou: lead

Study Sites (1)

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

Thessaloniki, Thessaloniki, 57010, Greece

Location

Related Publications (3)

• 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.

  PMID: 24156581 BACKGROUND

• 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.

  PMID: 30054030 BACKGROUND

• 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.

  PMID: 31438789 BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Panagiotis Givissis, Professor

  Aristotle University Of Thessaloniki

  STUDY CHAIR

Central Study Contacts

Eleni Karagergou, MD, PhD

CONTACT

+306972386716; krgeleni@gmail.com

Dimitrios Kitridis, MD

CONTACT

dkitridis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Plastic and Hand Surgeon

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)