Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Thumb Osteoarthritis
• Intervention / Treatment: Procedure: Trapeziectomy; Procedure: trapeziometacarpal limited excision

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, S-11883
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trapeziectomy; Standard simple trapeziectomy, no pins.	Procedure: Trapeziectomy; Simple trapeziectomy
Active Comparator: trapeziometacarpal limited excision; Trapeziometacarpal limited excision; Narrow pseudarthrosis of the trapeziometacarpal joint.	Procedure: trapeziometacarpal limited excision; Narrow pseudarthrosis CMC1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Maria Wilcke, MD PhD, Karolinska Instituet

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 21, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: TEvsTLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No