Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis

Thumb Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210687
• Other study ID #: TEvsTLE
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: February 1, 2028

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Maria Wilcke, MD PhD
• Phone: +46708294613
• Email: maria.wilcke[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Procedure:
• trapeziometacarpal limited excision
Narrow pseudarthrosis CMC1
• Trapeziectomy
Simple trapeziectomy

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Nelson Thumb score	0-100 p, higher score = less disability	Preoperatively, 1, 3 and 5 years postoperatively
Secondary	Change in EQ-5D	Weight mean value: 0=dead, 1= healthy	1, 3 and 5 years postoperatively
Secondary	Change in DASH - Disability of the Arm, Shoulder and Hand	0-100 p, higher score = more disability	Preoperatively, 1, 3 and 5 years postoperatively
Secondary	Change in PRWHE - Patient-Rated Wrist and Hand Evaluation	0-100 p, higher score = more disability	Preoperatively, 1, 3 and 5 years postoperatively
Secondary	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
Secondary	Change in PCS - Pain Catastrophizing Score	0-52, higher score = more pain catastrophizing	Preoperatively, 1, 3 and 5 years postoperatively
Secondary	Change in Thumb base motion	radial and palmar abduction of the first metacarpal (degrees).	Preoperatively, 1, 3 and 5 years postoperatively
Secondary	Change in thumb strength	Key pinch and pinch strength (Kg)	Preoperatively, 1, 3 and 5 years postoperatively