Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

17 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

80

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Climate change impact
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Readmission
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Hotspot analysis
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2025

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

11 juni 2026

Först inskickad som uppfyllde QC-kriterierna

17 juni 2026

Första postat (Faktisk)

18 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera