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

ConditionTrigger Digit

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-100

SponsorEleni Karagergou

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with single trigger finger that failed conservative treatment

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

A1 pulley release and pull out tenolysis
Procedure/Surgery
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/Surgery
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Pull out tenolysis groupActive comparator 1 intervention

Group B: Simple A1 pulley release groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eleni Karagergou

Lead sponsor

Aristotle University Of Thessaloniki

Sponsor institution

Source ClinicalTrials.gov

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