An interventional study of A1 pulley release and pull out tenolysis and Simple A1 pulley release in Trigger Digit, sponsored by Eleni Karagergou. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Eleni Karagergou · Not applicable, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Trigger Finger Disorder; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 66 across 75 interventional studies indexed under Trigger Finger Disorder.
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Exclusion Criteria:
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 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 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.
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.
Total active range of motion (AROM) of the affected finger
Comparison of total (AROM) between the groups. Measurements will be done with a goniometer
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months
Grip and Pinch strength
Comparison of grip and pinch strength between the groups, as measured by a dynamometer
Time frame: 6 weeks
Grip and Pinch strength
Comparison of grip and pinch strength between the groups, as measured by a dynamometer
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Rate of complications
All complications, such as swelling, wound dehiscence and infection, will be documented and rates will be compared between the groups
Time frame: Up to 3 months postoperatively
Plan to share: No
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