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Status unknownNCT04217928Updated Jan 6, 2020

Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis

An interventional study of Arthroscopic Debridement and Arthroscopic Hemi-Trapeziectomy with Mini TightRope in Osteoarthritis Thumb, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-06.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis Thumb

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Arthroscopic Debridement

    Patients who are randomized into this arm will receive arthroscopic debridement

    Procedure: Arthroscopic Debridement

  • Active comparator
    Arthroscopic Hemi-Trapeziectomy with Mini TightRope

    Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope

    Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope

Interventions

  • ProcedureArthroscopic Debridement

    Arthroscopic debridement will be performed under portal site local anaesthesia.

  • ProcedureArthroscopic Hemi-Trapeziectomy with Mini TightRope

    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.

06

What researchers measure

Primary outcomes

  1. Visual Analogue Scale (VAS) Pain Score at Rest and Exertion

    Pre-operative VAS pain score at rest and exertion will be measured

    Time frame: Pre-operative

  2. Visual Analogue Scale (VAS) Pain Score at Rest and Exertion

    VAS pain score at rest and exertion will be measured post-operatively

    Time frame: Post-op 3 months

  3. Visual Analogue Scale (VAS) Pain Score at Rest and Exertion

    VAS pain score at rest and exertion will be measured post-operatively

    Time frame: Post-op 6 months

  4. Visual Analogue Scale (VAS) Pain Score at Rest and Exertion

    VAS pain score at rest and exertion will be measured post-operatively

    Time frame: Post-op 12 months

  5. Visual Analogue Scale (VAS) Pain Score at Rest and Exertion

    VAS pain score at rest and exertion will be measured post-operatively

    Time frame: Post-op 24 months

  6. Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Time frame: Pre-operative

  7. Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Time frame: Post-op 3 months

  8. Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Time frame: Post-op 6 months

  9. Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Time frame: Post-op 12 months

  10. Short-Form Survey (SF-36)

    Generic health status instrument to assess quality of life

    Time frame: Post-op 24 months

  11. Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Time frame: Pre-operative

  12. Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Time frame: Post-op 3 months

  13. Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Time frame: Post-op 6 months

  14. Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Time frame: Post-op 12 months

  15. Disability of Arm, Shoulder and Hand (DASH) questionnaire

    Specially designed tool to assess upper extremity disability and symptoms

    Time frame: Post-op 24 months

  16. Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)

    Time frame: Pre-operative

  17. Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)

    Time frame: Post-op 3 months

  18. Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)

    Time frame: Post-op 6 months

  19. Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)

    Time frame: Post-op 12 months

  20. Patients' Satisfaction Score

    To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)

    Time frame: Post-op 24 months

  21. Grip Strength

    Will be measured in kg

    Time frame: Pre-operative

  22. Grip Strength

    Will be measured in kg

    Time frame: Post-op 3 months

  23. Grip Strength

    Will be measured in kg

    Time frame: Post-op 6 months

  24. Grip Strength

    Will be measured in kg

    Time frame: Post-op 12 months

  25. Grip Strength

    Will be measured in kg

    Time frame: Post-op 24 months

  26. Key and Tip Pinch

    Will be measured in kg

    Time frame: Pre-operative

  27. Key and Tip Pinch

    Will be measured in kg

    Time frame: Post-op 3 months

  28. Key and Tip Pinch

    Will be measured in kg

    Time frame: Post-op 6 months

  29. Key and Tip Pinch

    Will be measured in kg

    Time frame: Post-op 12 months

  30. Key and Tip Pinch

    Will be measured in kg

    Time frame: Post-op 24 months

  31. Range of Motion (ROM)

    ROM of interphalangeal joint and metacarpal joint of thumb will be measured

    Time frame: Pre-operative

  32. Range of Motion (ROM)

    ROM of interphalangeal joint and metacarpal joint of thumb will be measured

    Time frame: Post-op 3 months

  33. Range of Motion (ROM)

    ROM of interphalangeal joint and metacarpal joint of thumb will be measured

    Time frame: Post-op 6 months

  34. Range of Motion (ROM)

    ROM of interphalangeal joint and metacarpal joint of thumb will be measured

    Time frame: Post-op 12 months

  35. Range of Motion (ROM)

    ROM of interphalangeal joint and metacarpal joint of thumb will be measured

    Time frame: Post-op 24 months

  36. Kapandji Score

    A tool for assessing the opposition of the thumb

    Time frame: Pre-operative

  37. Kapandji Score

    A tool for assessing the opposition of the thumb

    Time frame: Post-op 3 months

  38. Kapandji Score

    A tool for assessing the opposition of the thumb

    Time frame: Post-op 6 months

  39. Kapandji Score

    A tool for assessing the opposition of the thumb

    Time frame: Post-op 12 months

  40. Kapandji Score

    A tool for assessing the opposition of the thumb

    Time frame: Post-op 24 months

  41. Complications

    Any complications related to the surgery will be documented

    Time frame: Post-operative up to 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04217928
Lead sponsor
Chinese University of Hong Kong
Responsible party
Michael Chu Kay MAK (Associate Consultant and Clinical Assistant Professor (Honorary), Chinese University of Hong Kong) — Principal investigator
First posted
Jan 6, 2020
Start date
Dec 10, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jan 6, 2020

Study contacts

Chu Kay Michael Mak, FRCSEd(Orth)
Contact
mmak@ort.cuhk.edu.hk
(852) 3505 2742
Wai Ping Fiona Yu, MPH
Contact
fionayuwp@cuhk.edu.hk

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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