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NCT Number: NCT06747962

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Thessaloniki, 57010, Greece

Location contact

Dimitrios Kitridis, MD

CONTACT

Eleni Karagergou, MD, PhD

CONTACT

Panagiotis Givissis, Professor

CONTACT

Panagiotis Givissis, Professor, Head of Orthopaedic

CONTACT

[email protected]

+302313307681

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Total active range of motion (AROM) of the affected finger

    Time frame: 2 weeks

    Comparison of total (AROM) between the groups. Measurements will be done with a goniometer

  2. Total active range of motion (AROM) of the affected finger

    Time frame: 6 weeks

    Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.

  3. Total active range of motion (AROM) of the affected finger

    Time frame: 3 months

    Comparison of total (AROM) between the groups. Measurements will be done with a goniometer.

  4. Visual Analog Scale (VAS) for pain relief

    Time frame: 2 weeks

    Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome

  5. Visual Analog Scale (VAS) for pain relief

    Time frame: 6 weeks

    Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome

  6. Visual Analog Scale (VAS) for pain relief

    Time frame: 3 months

    Comparison of the VAS for pain between the groups. Minimum 0, Maximum 10, higher scores mean a worse outcome

Secondary outcomes

  1. Grip and Pinch strength

    Time frame: 6 weeks

    Comparison of grip and pinch strength between the groups, as measured by a dynamometer

  2. Grip and Pinch strength

    Time frame: 3 months

    Comparison of grip and pinch strength between the groups, as measured by a dynamometer

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

    Time frame: 6 weeks

    Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

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

    Time frame: 3 months

    Comparison of the QuickDASH score between the two groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

Other outcomes

  1. Rate of complications

    Time frame: Up to 3 months postoperatively

    All complications, such as swelling, wound dehiscence and infection, will be documented and rates will be compared between the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitrios Kitridis, MD

CONTACT

[email protected]

Eleni Karagergou, MD, PhD

CONTACT

[email protected]

+306972386716

Sponsors and collaborators

Lead sponsor

Eleni Karagergou

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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