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
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Adults diagnosed with and operated for CMC1 OA (ICD-10 M18*)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline to 12 months in pain on load motion measured with the HAKIR questionnaire.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline to 12 months in pain on unloaded motion measured with the HAKIR questionnaire
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HAKIRcmc1
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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