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NCT Number: NCT03679793

Study of Open and Percutaneous Release of Acquired Trigger Thumb

Trigger finger, also known as trigger digit or stenosing tenovaginitis, is caused by a size mismatch between the flexor tendon and the A1 pulley, which is generally characterized by pain, swelling, the limitation of finger range of motion and a symptomatic locking or clicking sensation. Conservative treatment options include the application of non-steroidal anti-inflammatory drugs (NSAID), physiotherapy, electrotherapy, splinting and corticosteroid injection but not always effective with regard to frequent recurrence. Open surgical release of the A1 pulley remains the gold standard of treating symptomatic trigger finger. While percutaneous release is a minimal invasive alternative and gaining popularity for the index, middle ring and little fingers, investigations for the surgical efficacy on thumb is few and far between. Investigators believe that a carefully conducted operation with proper positioning of the thumb, wide-awake approach and meticulous technique can achieve similar efficacy and safety in terms of possibly less intraoperative pain, imperceptible scar and early return to daily activities and routine work.

The hypothesis of this study is that by using a proper positioning of thumb, wide awake approach and meticulous technique in conducting percutaneous release of trigger thumb can achieve similar efficacy and safety compared to that of open release surgical method. Moreover, percutaneous release of trigger thumb can generate less intraoperative pain, imperceptible scar and promote early return to routine work.

Hence, the objective of this study is to investigate and compare the safety, effectiveness and outcome of percutaneous release versus traditional open release for trigger thumbs.

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Key information

Conditions

Trigger Thumb Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Trigger Finger Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Clinical diagnosis of trigger thumb with Green's staging graded 2-4
  • Patients were unresponsive to conservative treatments for more than 3 months (Nonsteroidal anti-inflammatory drugs, physiotherapy, splinting, or injection of steroid)

Exclusion criteria

  • With history in rheumatoid arthritis
  • Unable to give verbal or written consent.

Treatment and study plan

Open Release Group

Procedure

Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger

Percutaneous Release Group

Procedure

Percutaneous release is a minimal invasive alternative surgical procedure

Primary outcomes

  1. Total volume of local anaesthetics injected

    Time frame: Intra-operative

    The total volume of local anaesthetics injected during operation

  2. Duration of surgery (in minutes)

    Time frame: Intra-operative

    The time (in minutes) needed for operation

  3. Surgical site pain

    Time frame: Intra-operative

    Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)

  4. Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)

    Time frame: Pre-operative

    Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness

  5. Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)

    Time frame: Post-op Day 7

    Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness

  6. Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)

    Time frame: Post-op Day 28

    Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness

  7. Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)

    Time frame: Post-op Day 90

    Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness

  8. Pre-operative Kapandji score

    Time frame: Pre-operative

    Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.

  9. Post-operative Kapandi score

    Time frame: Post-op Day 7

    Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.

  10. Post-operative Kapandi score

    Time frame: Post-op Day 28

    Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.

  11. Post-operative Kapandi score

    Time frame: Post-op Day 90

    Kapandji score is a tool useful for assessing the opposition of the thumb, based on where on their hand the patient is able to touch with the tip of their thumb.

  12. Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work

    Time frame: Pre-operative

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  13. Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work

    Time frame: Post-op Day 7

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  14. Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work

    Time frame: Post-op Day 28

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  15. Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work

    Time frame: Post-op Day 90

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  16. Pre-operative pain at rest

    Time frame: Pre-opeartively

    Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)

  17. Post-operative pain at rest

    Time frame: Post-op Day 7

    Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)

  18. Post-operative pain at rest

    Time frame: Post-op Day 28

    Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)

  19. Post-operative pain at rest

    Time frame: Post-op Day 90

    Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)

  20. Pre-operative pain on exertion

    Time frame: Pre-operative

    Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)

  21. Post-operative pain on exertion

    Time frame: Post-op Day 7

    Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)

  22. Post-operative pain on exertion

    Time frame: Post-op Day 28

    Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)

  23. Post-operative pain on exertion

    Time frame: Post-op Day 90

    Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)

  24. Satisfaction level after surgery

    Time frame: Post-op Day 7

    Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

  25. Satisfaction level after surgery

    Time frame: Post-op Day 28

    Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

  26. Satisfaction level after surgery

    Time frame: Post-op Day 91

    Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2018
Registry last updated
Sep 20, 2018

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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