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Study of Open and Percutaneous Release of Acquired Trigger Thumb

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ClinicalTrials.gov Identifier: NCT03679793
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr TSE Wing Lim, Chinese University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Trigger Thumb Procedure: Open Release Group Procedure: Percutaneous Release Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
Actual Study Start Date : August 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
Procedure: Open Release Group
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger

Experimental: Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure
Procedure: Percutaneous Release Group
Percutaneous release is a minimal invasive alternative surgical procedure




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679793


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

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Responsible Party: Dr TSE Wing Lim, Associate Consultant and Clinical Associate Professor (Honorary), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03679793     History of Changes
Other Study ID Numbers: Trigger thumb_Protocol_v02
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All collected data were from patients from study site and strictly confidential

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr TSE Wing Lim, Chinese University of Hong Kong:
Trigger Finger Disorder
Trigger Thumb
Minimally Invasive Surgical Procedures
Orthopedics
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases