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

Osteoarthritis Thumb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217928
• Other study ID #: RCT CMCJOA_Protocol_v1
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2020
• Source: Chinese University of Hong Kong
• Contact: Chu Kay Michael Mak, FRCSEd(Orth)
• Phone: (852) 3505 2742
• Email: mmak[@]ort.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Thumb

Intervention

Procedure:
• Arthroscopic Debridement
Arthroscopic debridement will be performed under portal site local anaesthesia.
• 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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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