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Study of Open and Percutaneous Release of Acquired Trigger Thumb

Primary Purpose

Trigger Thumb

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Open Release Group
Percutaneous Release Group
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Thumb focused on measuring Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open Release Group

Percutaneous Release Group

Arm Description

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

Percutaneous release is a minimal invasive alternative surgical procedure

Outcomes

Primary Outcome Measures

Total volume of local anaesthetics injected
The total volume of local anaesthetics injected during operation
Duration of surgery (in minutes)
The time (in minutes) needed for operation
Surgical site pain
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Pre-operative Kapandji score
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.
Post-operative Kapandi score
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.
Post-operative Kapandi score
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.
Post-operative Kapandi score
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.
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
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.
Pre-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Post-operative pain at rest
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Pre-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Post-operative pain on exertion
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Satisfaction level after surgery
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery

Secondary Outcome Measures

Full Information

First Posted
September 3, 2018
Last Updated
September 19, 2018
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03679793
Brief Title
Study of Open and Percutaneous Release of Acquired Trigger Thumb
Official Title
A Prospective Randomized Comparative Study of Open and Percutaneous Release of Acquired Trigger Thumb
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Thumb
Keywords
Trigger Finger Disorder, Trigger Thumb, Minimally Invasive Surgical Procedures, Orthopedics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Release Group
Arm Type
Active Comparator
Arm Description
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger.
Arm Title
Percutaneous Release Group
Arm Type
Experimental
Arm Description
Percutaneous release is a minimal invasive alternative surgical procedure
Intervention Type
Procedure
Intervention Name(s)
Open Release Group
Intervention Description
Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Release Group
Intervention Description
Percutaneous release is a minimal invasive alternative surgical procedure
Primary Outcome Measure Information:
Title
Total volume of local anaesthetics injected
Description
The total volume of local anaesthetics injected during operation
Time Frame
Intra-operative
Title
Duration of surgery (in minutes)
Description
The time (in minutes) needed for operation
Time Frame
Intra-operative
Title
Surgical site pain
Description
Visual analogue scale (VAS) was used to evaluate the pain at surgical site (0=no pain and 10=greatest pain)
Time Frame
Intra-operative
Title
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Description
Pre-operative active and passive ROM of IPJ and MPJ was measured to determine the joint stiffness
Time Frame
Pre-operative
Title
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Description
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Time Frame
Post-op Day 7
Title
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Description
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Time Frame
Post-op Day 28
Title
Active and passive range of motion (ROM) of interphalangeal joint (IPJ) and metacarpal-phalangeal joint (MPJ)
Description
Active and passive ROM of IPJ and MPJ was measured post-operatively to determine the joint stiffness
Time Frame
Post-op Day 90
Title
Pre-operative Kapandji score
Description
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.
Time Frame
Pre-operative
Title
Post-operative Kapandi score
Description
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.
Time Frame
Post-op Day 7
Title
Post-operative Kapandi score
Description
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.
Time Frame
Post-op Day 28
Title
Post-operative Kapandi score
Description
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.
Time Frame
Post-op Day 90
Title
Pre-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Description
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.
Time Frame
Pre-operative
Title
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Description
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.
Time Frame
Post-op Day 7
Title
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Description
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.
Time Frame
Post-op Day 28
Title
Post-operative Disabilities of the Arm, Shoulder and Hand (DASH) scores, including total, function, symptoms and work
Description
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.
Time Frame
Post-op Day 90
Title
Pre-operative pain at rest
Description
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Time Frame
Pre-opeartively
Title
Post-operative pain at rest
Description
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 7
Title
Post-operative pain at rest
Description
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 28
Title
Post-operative pain at rest
Description
Visual analogue scale (VAS) was used to evaluate the pain at rest (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 90
Title
Pre-operative pain on exertion
Description
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Time Frame
Pre-operative
Title
Post-operative pain on exertion
Description
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 7
Title
Post-operative pain on exertion
Description
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 28
Title
Post-operative pain on exertion
Description
Visual analogue scale (VAS) was used to evaluate the pain on exertion (0=no pain, 10=greatest pain)
Time Frame
Post-op Day 90
Title
Satisfaction level after surgery
Description
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Time Frame
Post-op Day 7
Title
Satisfaction level after surgery
Description
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Time Frame
Post-op Day 28
Title
Satisfaction level after surgery
Description
Subjects' satisfaction was evaluated (1=totally not satisfied; 10=totally satisfied) after surgery
Time Frame
Post-op Day 91

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All collected data were from patients from study site and strictly confidential

Learn more about this trial

Study of Open and Percutaneous Release of Acquired Trigger Thumb

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