Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
Primary Purpose
Osteoarthritis Thumb
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Arthroscopic Debridement
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Thumb
Eligibility Criteria
Inclusion Criteria:
- Patients with Eaton and Glickel stage II and III of thumb carpometacarpal joint osteoarthritis
- Age≥18 years old
- Failed to response to nonsurgical/conservative treatments including orthoses/splinting, activity modification, oral analgesics (e.g. nonsteroidal anti-inflammatory drugs), strengthening/flexibility exercises, and injections of corticosteroid or hyaluronic acid
- Willing to receive surgery
Exclusion Criteria:
- Patients received previous thumb surgery proximal to the interphalangeal joint (IPJ)
- Patients with prior traumatic thumb injuries (e.g. fracture, dislocation)
- Patients with significant metacarpophalangeal joint (MCPJ) pain
- With concurrent procedures on the thumb, e.g. ganglion removal, trigger thumb release
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arthroscopic Debridement
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Arm Description
Patients who are randomized into this arm will receive arthroscopic debridement
Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Pre-operative VAS pain score at rest and exertion will be measured
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength
Will be measured in kg
Grip Strength
Will be measured in kg
Grip Strength
Will be measured in kg
Grip Strength
Will be measured in kg
Grip Strength
Will be measured in kg
Key and Tip Pinch
Will be measured in kg
Key and Tip Pinch
Will be measured in kg
Key and Tip Pinch
Will be measured in kg
Key and Tip Pinch
Will be measured in kg
Key and Tip Pinch
Will be measured in kg
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji Score
A tool for assessing the opposition of the thumb
Kapandji Score
A tool for assessing the opposition of the thumb
Kapandji Score
A tool for assessing the opposition of the thumb
Kapandji Score
A tool for assessing the opposition of the thumb
Kapandji Score
A tool for assessing the opposition of the thumb
Complications
Any complications related to the surgery will be documented
Secondary Outcome Measures
Full Information
NCT ID
NCT04217928
First Posted
December 4, 2019
Last Updated
January 3, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04217928
Brief Title
Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
Official Title
Comparison of Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy With Mini TightRope on Patients With Thumb Carpometacarpal Joint Osteoarthritis - A Prospective Randomized Single-Blinded Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Patients with thumb carpometacarpal joint osteoarthritis usually suffer from pain, joint enlargement, inflammation, deformity and loss of function. Conservative treatments usually are the first-line interventions, unfortunately some of the patients do not response to such treatments and surgical treatment will then be considered.
Compare to other traditional surgical techniques, arthroscopic techniques has resulted in the potential to treat osteoarthritis in a minimally invasive approach, avoiding the need for a larger incision. Other advantages of arthroscopy include less scarring and joint contracture, less risk of neurovascular injury, improved appearance, limited morbidity and quicker recovery. Although arthroscopic methods have been proved to be effective, there is lack of high-level evidence based studies to conclude one operation is superior to another. Hence, this study is designed to investigate outcomes of the two arthroscopic surgical methods (arthroscopic debridement vs arthroscopic hemi-trapeziectomy with Mini TightRope). The result of this study is expected to provide significant evidence based clinical data for surgeons worldwide on treating the thumb carpometacarpal joint osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Thumb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor and biostatistician will be blinded
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Debridement
Arm Type
Active Comparator
Arm Description
Patients who are randomized into this arm will receive arthroscopic debridement
Arm Title
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Arm Type
Active Comparator
Arm Description
Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Debridement
Intervention Description
Arthroscopic debridement will be performed under portal site local anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Intervention Description
Anaesthesia, position and arthroscopy will be performed in the same way as for arthroscopic debridement, except the distal part of the trapezium will be resected to a depth of 3-4mm together with protruding osteophytes.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Description
Pre-operative VAS pain score at rest and exertion will be measured
Time Frame
Pre-operative
Title
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Description
VAS pain score at rest and exertion will be measured post-operatively
Time Frame
Post-op 3 months
Title
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Description
VAS pain score at rest and exertion will be measured post-operatively
Time Frame
Post-op 6 months
Title
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Description
VAS pain score at rest and exertion will be measured post-operatively
Time Frame
Post-op 12 months
Title
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Description
VAS pain score at rest and exertion will be measured post-operatively
Time Frame
Post-op 24 months
Title
Short-Form Survey (SF-36)
Description
Generic health status instrument to assess quality of life
Time Frame
Pre-operative
Title
Short-Form Survey (SF-36)
Description
Generic health status instrument to assess quality of life
Time Frame
Post-op 3 months
Title
Short-Form Survey (SF-36)
Description
Generic health status instrument to assess quality of life
Time Frame
Post-op 6 months
Title
Short-Form Survey (SF-36)
Description
Generic health status instrument to assess quality of life
Time Frame
Post-op 12 months
Title
Short-Form Survey (SF-36)
Description
Generic health status instrument to assess quality of life
Time Frame
Post-op 24 months
Title
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Description
Specially designed tool to assess upper extremity disability and symptoms
Time Frame
Pre-operative
Title
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Description
Specially designed tool to assess upper extremity disability and symptoms
Time Frame
Post-op 3 months
Title
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Description
Specially designed tool to assess upper extremity disability and symptoms
Time Frame
Post-op 6 months
Title
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Description
Specially designed tool to assess upper extremity disability and symptoms
Time Frame
Post-op 12 months
Title
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Description
Specially designed tool to assess upper extremity disability and symptoms
Time Frame
Post-op 24 months
Title
Patients' Satisfaction Score
Description
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Time Frame
Pre-operative
Title
Patients' Satisfaction Score
Description
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Time Frame
Post-op 3 months
Title
Patients' Satisfaction Score
Description
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Time Frame
Post-op 6 months
Title
Patients' Satisfaction Score
Description
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Time Frame
Post-op 12 months
Title
Patients' Satisfaction Score
Description
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Time Frame
Post-op 24 months
Title
Grip Strength
Description
Will be measured in kg
Time Frame
Pre-operative
Title
Grip Strength
Description
Will be measured in kg
Time Frame
Post-op 3 months
Title
Grip Strength
Description
Will be measured in kg
Time Frame
Post-op 6 months
Title
Grip Strength
Description
Will be measured in kg
Time Frame
Post-op 12 months
Title
Grip Strength
Description
Will be measured in kg
Time Frame
Post-op 24 months
Title
Key and Tip Pinch
Description
Will be measured in kg
Time Frame
Pre-operative
Title
Key and Tip Pinch
Description
Will be measured in kg
Time Frame
Post-op 3 months
Title
Key and Tip Pinch
Description
Will be measured in kg
Time Frame
Post-op 6 months
Title
Key and Tip Pinch
Description
Will be measured in kg
Time Frame
Post-op 12 months
Title
Key and Tip Pinch
Description
Will be measured in kg
Time Frame
Post-op 24 months
Title
Range of Motion (ROM)
Description
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Time Frame
Pre-operative
Title
Range of Motion (ROM)
Description
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Time Frame
Post-op 3 months
Title
Range of Motion (ROM)
Description
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Time Frame
Post-op 6 months
Title
Range of Motion (ROM)
Description
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Time Frame
Post-op 12 months
Title
Range of Motion (ROM)
Description
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Time Frame
Post-op 24 months
Title
Kapandji Score
Description
A tool for assessing the opposition of the thumb
Time Frame
Pre-operative
Title
Kapandji Score
Description
A tool for assessing the opposition of the thumb
Time Frame
Post-op 3 months
Title
Kapandji Score
Description
A tool for assessing the opposition of the thumb
Time Frame
Post-op 6 months
Title
Kapandji Score
Description
A tool for assessing the opposition of the thumb
Time Frame
Post-op 12 months
Title
Kapandji Score
Description
A tool for assessing the opposition of the thumb
Time Frame
Post-op 24 months
Title
Complications
Description
Any complications related to the surgery will be documented
Time Frame
Post-operative up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Eaton and Glickel stage II and III of thumb carpometacarpal joint osteoarthritis
Age≥18 years old
Failed to response to nonsurgical/conservative treatments including orthoses/splinting, activity modification, oral analgesics (e.g. nonsteroidal anti-inflammatory drugs), strengthening/flexibility exercises, and injections of corticosteroid or hyaluronic acid
Willing to receive surgery
Exclusion Criteria:
Patients received previous thumb surgery proximal to the interphalangeal joint (IPJ)
Patients with prior traumatic thumb injuries (e.g. fracture, dislocation)
Patients with significant metacarpophalangeal joint (MCPJ) pain
With concurrent procedures on the thumb, e.g. ganglion removal, trigger thumb release
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chu Kay Michael Mak, FRCSEd(Orth)
Phone
(852) 3505 2742
Email
mmak@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wai Ping Fiona Yu, MPH
Email
fionayuwp@cuhk.edu.hk
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chu Kay Michael MAK, FRCSEd(Orth)
Phone
(852) 3505 2742
Email
mmak@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Wai Ping Fiona Yu, MPH
Email
fionayuwp@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
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