Osteoarthritis ThumbNCT04217928
Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis
A study testing Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy with Mini TightRope in people with Osteoarthritis Thumb, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Thumb
- What is being tested?
- Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy with Mini TightRope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Dec 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Wai Ping Fiona Yu, MPH contact
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chu Kay Michael MAK, FRCSEd(Orth), (852) 3505 2742, mmak@ort.cuhk.edu.hk
Wai Ping Fiona Yu, MPH, fionayuwp@cuhk.edu.hk
About this study
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
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.
- Conditions
- Osteoarthritis Thumb
- Being tested
- Arthroscopic Debridement, Arthroscopic Hemi-Trapeziectomy with Mini TightRope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic DebridementProcedure or surgery
Arthroscopic debridement will be performed under portal site local anaesthesia.
Arthroscopic Hemi-Trapeziectomy with Mini TightRopeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Debridement | Active comparator | Patients who are randomized into this arm will receive arthroscopic debridement Receives: Procedure: Arthroscopic Debridement |
| Arthroscopic Hemi-Trapeziectomy with Mini TightRope | Active comparator | Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope Receives: Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Pre-operative VAS pain score at rest and exertion will be measured
Measured: Pre-operative
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Measured: Post-op 3 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Measured: Post-op 6 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Measured: Post-op 12 months
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
VAS pain score at rest and exertion will be measured post-operatively
Measured: Post-op 24 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Pre-operative
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Post-op 3 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Post-op 6 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Post-op 12 months
Short-Form Survey (SF-36)
Generic health status instrument to assess quality of life
Measured: Post-op 24 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Pre-operative
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Post-op 3 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Post-op 6 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Post-op 12 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Specially designed tool to assess upper extremity disability and symptoms
Measured: Post-op 24 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Pre-operative
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Post-op 3 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Post-op 6 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Post-op 12 months
Patients' Satisfaction Score
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Measured: Post-op 24 months
Grip Strength
Will be measured in kg
Measured: Pre-operative
Grip Strength
Will be measured in kg
Measured: Post-op 3 months
Grip Strength
Will be measured in kg
Measured: Post-op 6 months
Grip Strength
Will be measured in kg
Measured: Post-op 12 months
Grip Strength
Will be measured in kg
Measured: Post-op 24 months
Key and Tip Pinch
Will be measured in kg
Measured: Pre-operative
Key and Tip Pinch
Will be measured in kg
Measured: Post-op 3 months
Key and Tip Pinch
Will be measured in kg
Measured: Post-op 6 months
Key and Tip Pinch
Will be measured in kg
Measured: Post-op 12 months
Key and Tip Pinch
Will be measured in kg
Measured: Post-op 24 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Measured: Pre-operative
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Measured: Post-op 3 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Measured: Post-op 6 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Measured: Post-op 12 months
Range of Motion (ROM)
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Measured: Post-op 24 months
Kapandji Score
A tool for assessing the opposition of the thumb
Measured: Pre-operative
Kapandji Score
A tool for assessing the opposition of the thumb
Measured: Post-op 3 months
Kapandji Score
A tool for assessing the opposition of the thumb
Measured: Post-op 6 months
Kapandji Score
A tool for assessing the opposition of the thumb
Measured: Post-op 12 months
Kapandji Score
A tool for assessing the opposition of the thumb
Measured: Post-op 24 months
Complications
Any complications related to the surgery will be documented
Measured: Post-operative up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start10 Dec 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ThumbStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chu Kay MAK, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217928
- Sponsor's protocol ID
- RCT CMCJOA_Protocol_v1
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04217928
- Acronym / sponsor ID
- RCT CMCJOA_Protocol_v1
- Conditions
- Osteoarthritis Thumb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Debridement | Active comparator | Procedure: Arthroscopic DebridementPatients who are randomized into this arm will receive arthroscopic debridement |
| Arthroscopic Hemi-Trapeziectomy with Mini TightRope | Active comparator | Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRopePatients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic DebridementArthroscopic debridement will be performed under portal site local anaesthesia. | Procedure or surgery | Arthroscopic Debridement |
| Arthroscopic Hemi-Trapeziectomy with Mini TightRopeAnaesthesia, 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. | Procedure or surgery | Arthroscopic Hemi-Trapeziectomy with Mini TightRope |
Primary outcome
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time frame: Pre-operative
Pre-operative VAS pain score at rest and exertion will be measured
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time frame: Post-op 3 months
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time frame: Post-op 6 months
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time frame: Post-op 12 months
VAS pain score at rest and exertion will be measured post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion
Time frame: Post-op 24 months
VAS pain score at rest and exertion will be measured post-operatively
Short-Form Survey (SF-36)
Time frame: Pre-operative
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Time frame: Post-op 3 months
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Time frame: Post-op 6 months
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Time frame: Post-op 12 months
Generic health status instrument to assess quality of life
Short-Form Survey (SF-36)
Time frame: Post-op 24 months
Generic health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Pre-operative
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Post-op 3 months
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Post-op 6 months
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Post-op 12 months
Specially designed tool to assess upper extremity disability and symptoms
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time frame: Post-op 24 months
Specially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction Score
Time frame: Pre-operative
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
Time frame: Post-op 3 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
Time frame: Post-op 6 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
Time frame: Post-op 12 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Patients' Satisfaction Score
Time frame: Post-op 24 months
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip Strength
Time frame: Pre-operative
Will be measured in kg
Grip Strength
Time frame: Post-op 3 months
Will be measured in kg
Grip Strength
Time frame: Post-op 6 months
Will be measured in kg
Grip Strength
Time frame: Post-op 12 months
Will be measured in kg
Grip Strength
Time frame: Post-op 24 months
Will be measured in kg
Key and Tip Pinch
Time frame: Pre-operative
Will be measured in kg
Key and Tip Pinch
Time frame: Post-op 3 months
Will be measured in kg
Key and Tip Pinch
Time frame: Post-op 6 months
Will be measured in kg
Key and Tip Pinch
Time frame: Post-op 12 months
Will be measured in kg
Key and Tip Pinch
Time frame: Post-op 24 months
Will be measured in kg
Range of Motion (ROM)
Time frame: Pre-operative
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
Time frame: Post-op 3 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
Time frame: Post-op 6 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
Time frame: Post-op 12 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Range of Motion (ROM)
Time frame: Post-op 24 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji Score
Time frame: Pre-operative
A tool for assessing the opposition of the thumb
Kapandji Score
Time frame: Post-op 3 months
A tool for assessing the opposition of the thumb
Kapandji Score
Time frame: Post-op 6 months
A tool for assessing the opposition of the thumb
Kapandji Score
Time frame: Post-op 12 months
A tool for assessing the opposition of the thumb
Kapandji Score
Time frame: Post-op 24 months
A tool for assessing the opposition of the thumb
Complications
Time frame: Post-operative up to 2 years
Any complications related to the surgery will be documented
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Ping Fiona Yu, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy with Mini TightRope in people with Osteoarthritis Thumb, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chu Kay Michael Mak, FRCSEd(Orth) ((852) 3505 2742, mmak@ort.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) Pain Score at Rest and Exertion (time frame: Pre-operative). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.