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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07657039
Acronym
USELESS
Enrollment
80
Registered
2026-06-18
Start date
2025-09-01
Completion date
2027-12-01
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Environment, Waste Output

Keywords

Climate change impact, greenhouse gases, environment, Life Cycle Assessment, Single-use materials

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Climate change impactData cwill be collected during 12 months for each groupMean 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.

Secondary

MeasureTime frameDescription
Readmissionwithin 90 days of the performed sugeryReadmission to hospital within 90 days of the procedure. Admission cause must be related the surgical proceure, e.g. surgical site infection demanding iv antibiotics.
Combustible wasteAll consecutive suergeries for twelve months in each groupWeight 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.
CostsAll consecutive suergeries for twelve months in each groupDifference 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.
InfectionsWithin 90 days of surgerySurgical 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.

Countries

Sweden

Contacts

CONTACTMarianne Smith, MD
marianne.smith@regionstockholm.se+46737803594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026