Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Not Applicable

Recruiting

• Conditions: Thumb Osteoarthritis
• Interventions: Procedure: trapeziometacarpal limited excision; Procedure: Trapeziectomy

• Registration Number: NCT04210687
• Lead Sponsor: Karolinska Institutet

Brief Summary

A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-21
• Study First Posted: 2019-12-26
• Study Start: 2020-03-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07
• Primary Completion: 2026-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
• Pain at rest.
• Conservative treatment >6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)

Read More

Exclusion Criteria

• Rheumatoid arthritis.
• Ongoing infection in the hand or wrist. -
• History of gout or pseudo gout.
• Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
• Intra-articular injection in the affected joint within 6 months.
• Eaton Littler class 4 (STT joint involved).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trapeziometacarpal limited excision	trapeziometacarpal limited excision	Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.
Trapeziectomy	Trapeziectomy	Standard simple trapeziectomy, no pins.

Primary Outcome Measures

Name	Time	Method
Change in pain on load NRS (numerical rating scale)	Preoperatively, 1, 3 and 5 years postoperatively	Change in rated pain on load from preoperatively to 1, 3 and 5 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Change in DASH - Disability of the Arm, Shoulder and Hand	Preoperatively, 1, 3 and 5 years postoperatively	0-100 p, higher score = more disability
Change in HADS - Change hospital Anxiety and Depression score	Preoperatively, 1, 3 and 5 years postoperatively	2 subscores for anxiety (0-21P) and depression (0-21p), higher score = worse
Change in PCS - Pain Catastrophizing Score	Preoperatively, 1, 3 and 5 years postoperatively	0-52, higher score = more pain catastrophizing
Change in Thumb base motion	Preoperatively, 1, 3 and 5 years postoperatively	radial and palmar abduction of the first metacarpal (degrees).
Change in Nelson Thumb score	Preoperatively, 1, 3 and 5 years postoperatively	0-100 p, higher score = less disability
Change in EQ-5D	1, 3 and 5 years postoperatively	Weight mean value: 0=dead, 1= healthy
Change in PRWHE - Patient-Rated Wrist and Hand Evaluation	Preoperatively, 1, 3 and 5 years postoperatively	0-100 p, higher score = more disability
Change in thumb strength	Preoperatively, 1, 3 and 5 years postoperatively	Key pinch and pinch strength (Kg)

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden