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USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery (USELESS)

17 de junio de 2026 actualizado por: Cecilia Mellstrand Navarro, Karolinska Institutet

USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery.

A prospective comparative cohort study with the objective to quantify and compare carbon dioxide equivalent (CO₂e) emissions from orthopedic surgeries performed in two different operating room (OR) settings using different sets of materials and staff.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

Background: Human health depends on the stability of Earth's ecological systems. Healthcare, guided by the principle "first do no harm," paradoxically contributes to this destabilization: globally, it accounts for ~5% of greenhouse gas (GHG) emissions, with orthopedic care among the most resource-intensive domains. It is imperative that the health sector finds ways to reduce emissions while still providing care with preserved quality and quantity. Use of single-use materials has been found to yield a significant part of emissions from orthopedic surgeries. Performing minor surgeries in procedure rooms instead of the operating room can reduce emissions and waste. Moreover, a small portion of products accounts for most of an operation's carbon footprint, suggesting that targeted measures may have substantial impact.

Carbon emission represents only one dimension of healthcare's environmental burden. Life Cycle Assessment (LCA) enables quantification of impacts across categories such as toxicity, particulate matter formation, resource depletion, water consumption, land use, ozone formation, and ecosystem effects. These categories are relevant in orthopedics, where products commonly contain e.g. polyvinyl chloride (PVC), di(2-ethylhexyl) phthalate (DEHP), and per- and polyfluoroalkyl substances (PFAS). Moreover, large quantities of nonrecyclable plastics are used. Transitioning from single-use to reusable products can reduce GHG emissions significantly, though further studies are needed to ensure clinical safety.

Carbon emission represents only one dimension of healthcare's environmental burden. Life Cycle Assessment (LCA) enables quantification of impacts across categories such as toxicity, particulate matter formation, resource depletion, water consumption, land use, ozone formation, and ecosystem effects. These categories are relevant in orthopedics, where products commonly contain e.g. polyvinyl chloride (PVC), di(2-ethylhexyl) phthalate (DEHP), and per- and polyfluoroalkyl substances (PFAS). Moreover, large quantities of nonrecyclable plastics are used [9]. Transitioning from single-use to reusable products can reduce GHG emissions significantly, though further studies are needed to ensure clinical safety. Population: Age ≥18 years undergoing release of carpal tunnel or trigger finger, wound revision or amputation of finger or toe, extraction of osteosynthesis material or suturing of extensor tendon (hand or foot) at Danderyd's Hospital. There are no exclusion criteria.

Intervention: Procedures performed in a procedure room using a reduced material set at the outpatient clinic under local anesthetics only. Control: Procedures performed in an operating room (OR) using a standard OR set up with available anesthesiology assistance.

This study hopes to answer the question: How do climate change impact differ between minor orthopedic procedures performed in a conventional operating theatre compared with procedures in an outpatient clinic procedure room with a reduced set of material?

Primary outcome: CO₂e per functional unit. Secondary outcomes: Complications (infection, readmission), combustible waste (kg) and costs (staff and material). Hotspot analysis identifying major contributors to emissions. The functional unit is defined as one performed surgery.

Environmental impacts will be assessed using Life Cycle Assessment (LCA) according to the four standard phases: (1) goal and scope definition, (2) life cycle inventory (LCI), (3) life cycle impact assessment (LCIA), and (4) interpretation including sensitivity and uncertainty analyses. System boundaries will be cradle-to-grave when complete data are available and otherwise gate-to-gate for single-use products lacking published LCAs. Identical system boundaries will be applied within each study to ensure comparability between intervention and control groups. Life cycle inventories will include materials, pharmaceuticals, reusable and single-use equipment, sterilization, energy consumption, waste handling, inpatient care, and staffing. Detailed inventories of surgical procedures will be collected prospectively at Danderyd Hospital, including article numbers, quantities, and weights of materials, as well as disposal weights. CO₂e emissions will primarily be calculated using manufacturer LCAs; where unavailable, emissions will be estimated from material composition and weight using established databases (e.g., Inventory of Carbon and Energy) and published templates for reusable materials and energy use. Mean emissions per procedure or treatment pathway will be calculated and compared between groups.

Tipo de estudio

De observación

Inscripción (Estimado)

80

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

All patients above the age of 18 undergoing stated procedures at Danderyd's hospital.

Descripción

Inclusion Criteria:

  • The following surgeries will be included: release of carpal tunnel or trigger finger, wound revision or amputation of finger or toe, extraction of osteosynthesis material or suturing of extensor tendon (hand or foot) at Danderyd's Hospital.

Exclusion Criteria:

  • None

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Control group
Patients undergoing surgical procedures in an operating room at the day surgery department
Intervention group
Patients undergoing surgical procedures in the procedure room at the orthopedic outpatient clinic

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Climate change impact
Periodo de tiempo: Data cwill be collected during 12 months for each group
Mean carbon dioxide equivalent (CO₂e) emissions expressed in kgs per functional unit defined as one performed surgery. All single-use materials consumed during an operation will be registrered, categorized, weighted and converted into CO₂e using exsisting LCAs or databases. Energy comsuption for machines in the OR, heating and ventilation of the OR and for sterilization of reusable materials will be converted into CO2e using existing databases. Water usage for sterilization will be calculated and converted into CO₂e using databases.
Data cwill be collected during 12 months for each group

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Readmission
Periodo de tiempo: within 90 days of the performed sugery
Readmission to hospital within 90 days of the procedure. Admission cause must be related the surgical proceure, e.g. surgical site infection demanding iv antibiotics.
within 90 days of the performed sugery
Combustible waste
Periodo de tiempo: All consecutive suergeries for twelve months in each group
Weight of waste generated after each surgery measured in kgs. Staff in the OR will collect all waste in one or two plastic bags and weigh them using a hade scale INF model KBE-BHC025-11 D hand scale. The weight is recorded in kilograms in the study protocol in the OR.
All consecutive suergeries for twelve months in each group
Costs
Periodo de tiempo: All consecutive suergeries for twelve months in each group
Difference in costs for material and staff. Costs for all singe-use items will be collected from the purcahse department and recorded in SEK intitiallt before conversion to € at the time or data analysis. Costs for reuseable items will be collected and a value calculated for each usage will be obtained. Energy usage will be calculated in kWh and water consumtion will be measured in cubic meters and a converted into SEK/€ using price lists obtained from the Hospital. A mean value for costs for each staff category (e.g. doctor, nurse) per hour will be obtained from the hospital and mutiplied by the OR time.
All consecutive suergeries for twelve months in each group
Infections
Periodo de tiempo: Within 90 days of surgery
Surgical site infection following the procedure. Patients charts will be examined after 90 days and if any antibiotics covering skin pathogens (e.g. Flukloxacillin, Clindamycin) has been perscribed by any caregiver during the period it will be assumed to be a positive value.
Within 90 days of surgery

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Hotspot analysis
Periodo de tiempo: All consecutive suergeries for twelve months in each group
Identification of major contributors to emissions by categorizing all activity data that contributes to emissions and calculated as a percentage of the primary endpoint; CO₂e expressed i kgs per fuctional unit (one surgery). Categories will include but not be restricted to; single-use items, manufacturing and usage of reusable items, egergy comsuption by machines in the OR, energy comsuption for heating and ventilation and energy and water consumption for sterilization of resuable items.
All consecutive suergeries for twelve months in each group

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2025

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-02587-01

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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