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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04217928
Enrollment
60
Registered
2020-01-06
Start date
2019-12-10
Completion date
2023-12-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Thumb

Brief 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.

Interventions

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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes assessor and biostatistician will be blinded

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS) Pain Score at Rest and ExertionPre-operativePre-operative VAS pain score at rest and exertion will be measured
Short-Form Survey (SF-36)Pre-operativeGeneric health status instrument to assess quality of life
Disability of Arm, Shoulder and Hand (DASH) questionnairePre-operativeSpecially designed tool to assess upper extremity disability and symptoms
Patients' Satisfaction ScorePre-operativeTo grade the subjects' satisfaction regarding to their thumb conditions (0=totally not satisfied; 10=fully satisfied)
Grip StrengthPre-operativeWill be measured in kg
Key and Tip PinchPre-operativeWill be measured in kg
Range of Motion (ROM)Pre-operativeROM of interphalangeal joint and metacarpal joint of thumb will be measured
Kapandji ScorePre-operativeA tool for assessing the opposition of the thumb
ComplicationsPost-operative up to 2 yearsAny complications related to the surgery will be documented

Countries

Hong Kong

Contacts

Primary ContactChu Kay Michael Mak, FRCSEd(Orth)
mmak@ort.cuhk.edu.hk(852) 3505 2742
Backup ContactWai Ping Fiona Yu, MPH
fionayuwp@cuhk.edu.hk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026