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

NCT ID: NCT04217928

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Thumb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor and biostatistician will be blinded

Study Groups

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Arthroscopic Debridement

Patients who are randomized into this arm will receive arthroscopic debridement

Group Type ACTIVE_COMPARATOR

Arthroscopic Debridement

Intervention Type PROCEDURE

Arthroscopic debridement will be performed under portal site local anaesthesia.

Arthroscopic Hemi-Trapeziectomy with Mini TightRope

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

Group Type ACTIVE_COMPARATOR

Arthroscopic Hemi-Trapeziectomy with Mini TightRope

Intervention Type PROCEDURE

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.

Interventions

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Arthroscopic Debridement

Arthroscopic debridement will be performed under portal site local anaesthesia.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Michael Chu Kay MAK

Associate Consultant and Clinical Assistant Professor (Honorary)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Chu Kay Michael Mak, FRCSEd(Orth)

Role: CONTACT

(852) 3505 2742

Wai Ping Fiona Yu, MPH

Role: CONTACT

Facility Contacts

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Chu Kay Michael MAK, FRCSEd(Orth)

Role: primary

(852) 3505 2742

Wai Ping Fiona Yu, MPH

Role: backup

Other Identifiers

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RCT CMCJOA_Protocol_v1

Identifier Type: -

Identifier Source: org_study_id

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