CMC-1 Replacement Arthroplasty Versus Trapeziectomy

NCT07583628 | Completed

• 1 other identifier: HAKIRcmc1
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Thumb carpometacarpal (CMC-1) osteoarthritis is a common condition causing pain and disability, particularly among middle-aged and older women. When non-operative treatment fails, surgery is indicated. In Sweden, trapeziectomy (TE), with or without tendon-based adjuncts, is the standard procedure and recommended in the National Care Program introduced in 2022. However, total joint arthroplasty (TJA) has gained popularity because of reports of faster recovery and improved early function, although concerns remain regarding complications, durability, and cost. Comparative studies are therefore needed. The aim of this study is to compare patient-reported outcomes after dual-mobility TJA versus TE, with or without tendon-based adjuncts, for CMC-1 osteoarthritis using data from the Swedish Hand Surgery Quality Register (HAKIR). To reduce bias in observational data, the study will emulate a hypothetical randomized target trial. This registry-based cohort study will include adults aged 45 years or older undergoing primary surgery for CMC-1 osteoarthritis. Patients with previous CMC-1 surgery, bilateral procedures, inflammatory joint disease, or extensive missing baseline data will be excluded. Baseline is defined as the date of surgery, and patients will be followed using patient-reported outcome measures collected preoperatively and at 3 and 12 months. The primary outcome is change in pain on load measured with the HQ-8 questionnaire at 12 months. Secondary outcomes include pain at 3 months, low pain levels at 12 months, other HQ-8 domains, QuickDASH score, patient satisfaction, grip and pinch strength, thumb range of motion, time to reoperation, and postoperative complications. Potential confounders will be identified using a directed acyclic graph (DAG). Measured confounders include age, sex, surgical centre, calendar year, baseline pain, baseline function, and smoking. Unmeasured factors such as surgeon preference, patient preference, and disease severity not captured in the registry may still cause residual confounding. Primary analyses will use linear mixed-effects regression to compare adjusted mean pain outcomes between groups at 12 months while accounting for clustering by patient and centre. Secondary outcomes will be analysed using ordinal logistic regression, Cox proportional hazards regression, and logistic regression. Missing data will be handled using multiple imputation, and sensitivity analyses using inverse probability weighting will assess the impact of reoperations and selection bias

Conditions

Osteoarthritis in the Carpometacarpal (CMC) Joint

Keywords

thumb base; osteoarthritis; PROM; trapeziectomy; joint replacement; CMC-1

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.

  Pain on load motion assessed using the HQ-8 patient-reported outcome questionnaire. Responses are reported on an 11-point numerical rating scale ranging from 0 (no symptoms or discomfort) to 100 (worst imaginable symptoms or discomfort) in increments of 10.

  Baseline and 12 months postoperatively

Secondary Outcomes (12)

• Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire

  Baseline and 12 months after surgery

• Change from baseline to 12 months in pain at rest measured with the HQ-8 questionnaire

  Baseline and 12 months postoperatively

• Change from baseline to 12 months in stiffness measured with the HQ-8 questionnaire

  Baseline and 12 months postoperatively

• Change from baseline to 12 months in weakness measured with the HQ-8 questionnaire

  Baseline and 12 months postoperatively

• Change from baseline to 12 months in activities of daily living measured with the HQ-8 questionnaire

  Baseline and 12 months postoperatively

Study Arms (1)

Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*)

1. Trapeziectomy (TE) with or without tendon adjunct according to routine practice with Flexor Carpi Radialis/Extensor Carpi Radialis Longus/Abductor Pollicis Longus/Palmaris Longus). 2. Total joint thumb base dual mobility arthroplastyDual mobility TJA

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients are adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.

You may qualify if:

• adults aged ≥45 years with a diagnosis of CMC-1 osteoarthritis (ICD-10 code M18) who have failed non-operative treatment and are scheduled for primary CMC-1 surgery.

You may not qualify if:

• Bilateral CMC-1 surgery or other simultaneous hand interventions
• Previous CMC-1 surgery on the affected hand
• Inflammatory joint disease affecting the hands (e.g., rheumatoid arthritis, systemic lupus erythematosus)
• % missing baseline (preoperative) variables

Sponsors & Collaborators

• Karolinska Institutet: lead
• Erasmus Medical Center: collaborator

MeSH Terms

Conditions

Capillary Malformations, Congenital, 1; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start: January 1, 2011
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 13, 2026

Record last verified: 2026-04