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

17 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

80

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Climate change impact
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Readmission
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Hotspot analysis
Ramy czasowe: 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

Współpracownicy i badacze

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Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 września 2025

Zakończenie podstawowe (Szacowany)

31 sierpnia 2027

Ukończenie studiów (Szacowany)

1 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

11 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 2025-02587-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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