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

January 3, 2020 updated by: Michael Chu Kay MAK, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arthroscopic Debridement
Patients who are randomized into this arm will receive arthroscopic debridement
Procedure: Arthroscopic Debridement
Arthroscopic debridement will be performed under portal site local anaesthesia.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-operative
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
Post-op 3 months
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
Post-op 6 months
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
Post-op 12 months
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
Post-op 24 months
Short-Form Survey (SF-36)
Time Frame: Pre-operative
Generic health status instrument to assess quality of life
Pre-operative
Short-Form Survey (SF-36)
Time Frame: Post-op 3 months
Generic health status instrument to assess quality of life
Post-op 3 months
Short-Form Survey (SF-36)
Time Frame: Post-op 6 months
Generic health status instrument to assess quality of life
Post-op 6 months
Short-Form Survey (SF-36)
Time Frame: Post-op 12 months
Generic health status instrument to assess quality of life
Post-op 12 months
Short-Form Survey (SF-36)
Time Frame: Post-op 24 months
Generic health status instrument to assess quality of life
Post-op 24 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Pre-operative
Specially designed tool to assess upper extremity disability and symptoms
Pre-operative
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Post-op 3 months
Specially designed tool to assess upper extremity disability and symptoms
Post-op 3 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Post-op 6 months
Specially designed tool to assess upper extremity disability and symptoms
Post-op 6 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Post-op 12 months
Specially designed tool to assess upper extremity disability and symptoms
Post-op 12 months
Disability of Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Post-op 24 months
Specially designed tool to assess upper extremity disability and symptoms
Post-op 24 months
Patients' Satisfaction Score
Time Frame: Pre-operative
To grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Pre-operative
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)
Post-op 3 months
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)
Post-op 6 months
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)
Post-op 12 months
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)
Post-op 24 months
Grip Strength
Time Frame: Pre-operative
Will be measured in kg
Pre-operative
Grip Strength
Time Frame: Post-op 3 months
Will be measured in kg
Post-op 3 months
Grip Strength
Time Frame: Post-op 6 months
Will be measured in kg
Post-op 6 months
Grip Strength
Time Frame: Post-op 12 months
Will be measured in kg
Post-op 12 months
Grip Strength
Time Frame: Post-op 24 months
Will be measured in kg
Post-op 24 months
Key and Tip Pinch
Time Frame: Pre-operative
Will be measured in kg
Pre-operative
Key and Tip Pinch
Time Frame: Post-op 3 months
Will be measured in kg
Post-op 3 months
Key and Tip Pinch
Time Frame: Post-op 6 months
Will be measured in kg
Post-op 6 months
Key and Tip Pinch
Time Frame: Post-op 12 months
Will be measured in kg
Post-op 12 months
Key and Tip Pinch
Time Frame: Post-op 24 months
Will be measured in kg
Post-op 24 months
Range of Motion (ROM)
Time Frame: Pre-operative
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Pre-operative
Range of Motion (ROM)
Time Frame: Post-op 3 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 3 months
Range of Motion (ROM)
Time Frame: Post-op 6 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 6 months
Range of Motion (ROM)
Time Frame: Post-op 12 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 12 months
Range of Motion (ROM)
Time Frame: Post-op 24 months
ROM of interphalangeal joint and metacarpal joint of thumb will be measured
Post-op 24 months
Kapandji Score
Time Frame: Pre-operative
A tool for assessing the opposition of the thumb
Pre-operative
Kapandji Score
Time Frame: Post-op 3 months
A tool for assessing the opposition of the thumb
Post-op 3 months
Kapandji Score
Time Frame: Post-op 6 months
A tool for assessing the opposition of the thumb
Post-op 6 months
Kapandji Score
Time Frame: Post-op 12 months
A tool for assessing the opposition of the thumb
Post-op 12 months
Kapandji Score
Time Frame: Post-op 24 months
A tool for assessing the opposition of the thumb
Post-op 24 months
Complications
Time Frame: Post-operative up to 2 years
Any complications related to the surgery will be documented
Post-operative up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT CMCJOA_Protocol_v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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