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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Unknown

Conditions

Osteoarthritis Thumb

Treatments

Procedure: Arthroscopic Debridement
Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope

Study type

Interventional

Funder types

Other

Identifiers

NCT04217928
RCT CMCJOA_Protocol_v1

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Arthroscopic Debridement
Active Comparator group
Description:
Patients who are randomized into this arm will receive arthroscopic debridement
Treatment:
Procedure: Arthroscopic Debridement
Arthroscopic Hemi-Trapeziectomy with Mini TightRope
Active Comparator group
Description:
Patients who are randomized into this arm will receive arthroscopic hemi-trapeziectomy with mini tightrope
Treatment:
Procedure: Arthroscopic Hemi-Trapeziectomy with Mini TightRope

Trial contacts and locations

1

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Central trial contact

Wai Ping Fiona Yu, MPH; Chu Kay Michael Mak, FRCSEd(Orth)

Data sourced from clinicaltrials.gov

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