CMC-1 Replacement Arthroplasty Versus Trapeziectomy
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
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
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.
Exclusion Criteria:
- 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)
- 30% missing baseline (preoperative) variables
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.
Lasso di tempo: Baseline and 12 months postoperatively
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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.
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Baseline and 12 months postoperatively
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire
Lasso di tempo: Baseline and 12 months after surgery
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Pain on unloaded 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.
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Baseline and 12 months after surgery
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Change from baseline to 12 months in pain at rest measured with the HQ-8 questionnaire
Lasso di tempo: Baseline and 12 months postoperatively
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Pain at rest 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.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in stiffness measured with the HQ-8 questionnaire
Lasso di tempo: Baseline and 12 months postoperatively
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Stiffness 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.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in weakness measured with the HQ-8 questionnaire
Lasso di tempo: Baseline and 12 months postoperatively
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Weakness 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.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in activities of daily living measured with the HQ-8 questionnaire
Lasso di tempo: Baseline and 12 months postoperatively
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Activities of daily living 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.
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Baseline and 12 months postoperatively
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Change from baseline to 12 months in Quick Disabilities of Arm, Shoulder and Hand Questionnaire (Quick DASH)
Lasso di tempo: Baseline and 12 months postoperatively
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Upper extremity disability and symptoms assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Scores range from 0 to 100, where higher scores indicate greater disability and worse upper extremity function.
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Baseline and 12 months postoperatively
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Change in key pinch strength
Lasso di tempo: Baseline and 12 months postoperatively
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kg
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Baseline and 12 months postoperatively
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Change in grip strength
Lasso di tempo: Baseline and 12 months postoperatively
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jamar (kg)
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Baseline and 12 months postoperatively
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Change in thumb radial abduction
Lasso di tempo: Baseline and 12 months postoperatively
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radial abduction (degrees)
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Baseline and 12 months postoperatively
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Change in thumb plamar abduction
Lasso di tempo: From preoperatively to 12 months postoperatively
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palmar abduction (degrees)
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From preoperatively to 12 months postoperatively
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Time to first reoperation* of the index hand
Lasso di tempo: primary horizon: 12 months; secondary: maximum available follow-up
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primary horizon: 12 months; secondary: maximum available follow-up
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Risk of any (non-reoperation) complication within 12 months
Lasso di tempo: within 12 months after surgery
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occurrence of any registered postoperative complication of the index hand recorded in HAKIR
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within 12 months after surgery
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Collaboratori e investigatori
Sponsor
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HAKIRcmc1
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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