EnvironmentUSELESSNCT07657039
USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery
An observational study of Environment and Waste Output, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Environment, Waste Output
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients above the age of 18 undergoing stated procedures at Danderyd's hospital.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Danderyd's Hospital
Stockholm
Marianne Smith, +46737803594, marianne.smith@regionstockholm.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Environment, Waste Output
- Keywords
- Climate change impact, greenhouse gases, environment, Life Cycle Assessment, Single-use materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Climate change impact
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.
Measured: Data cwill be collected during 12 months for each group
Secondary outcomes (4)
Readmission
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.
Measured: within 90 days of the performed sugery
Combustible waste
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.
Measured: All consecutive suergeries for twelve months in each group
Costs
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.
Measured: All consecutive suergeries for twelve months in each group
Infections
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.
Measured: Within 90 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EnvironmentStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilia Mellstrand Navarro, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657039
- Sponsor's protocol ID
- 2025-02587-01
- Other IDs
- 2025
- Acronym
- USELESS
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keil M, Viere T, Helms K, Rogowski W. The impact of switching from single-use to reusable healthcare products: a transparency checklist and systematic review of life-cycle assessments. Eur J Public Health. 2023 Feb 3;33(1):56-63. doi: 10.1093/eurpub/ckac174.
PubMed 364337878: Ted Schettler, M., Polyvinyl chloride in health care. 2020.
7: WOLF, M.-A., et al., International reference life cycle data system (ILCD) handbook-general guide for life cycle assessment-detailed guidance. 2010.
Rizan C, Lillywhite R, Reed M, Bhutta MF. The carbon footprint of products used in five common surgical operations: identifying contributing products and processes. J R Soc Med. 2023 Jun;116(6):199-213. doi: 10.1177/01410768231166135. Epub 2023 Apr 13.
PubMed 37054734Grothaus O, Jorgensen A, Maughan G, Anto M, Kazmers NH, Garcia BN. Carbon Footprint of Open Carpal Tunnel Release Surgery Performed in the Procedure Room Versus Operating Room Setting. J Hand Surg Am. 2024 Jun;49(6):576-582. doi: 10.1016/j.jhsa.2024.03.014. Epub 2024 May 6.
PubMed 38713110Rizan C, Steinbach I, Nicholson R, Lillywhite R, Reed M, Bhutta MF. The Carbon Footprint of Surgical Operations: A Systematic Review. Ann Surg. 2020 Dec;272(6):986-995. doi: 10.1097/SLA.0000000000003951.
PubMed 325162303: Boiko, P., et al., Environmental life cycle assessment of surgical versus conservative care pathways for an anterior cruciate ligament injury. Journal of cleaner production, 2025. 535: p. 147136.
Eidmann A, Geiger F, Heinz T, Jakuscheit A, Docheva D, Horas K, Stratos I, Rudert M. Our Impact on Global Warming: A Carbon Footprint Analysis of Orthopaedic Operations. J Bone Joint Surg Am. 2024 Nov 6;106(21):1971-1977. doi: 10.2106/JBJS.24.00212. Epub 2024 Sep 19.
PubMed 395037161:Pichler, P.-P., et al., International comparison of health care carbon footprints. Environmental research letters, 2019. 14(6): p. 064004
Shah S, Morris H, Thiagarajah S, Gordon A, Sharma S, Haslam P, Garcia J, Ali F. Handling 'carbon footprint' in orthopaedics. Ann R Coll Surg Engl. 2024 Jul;106(6):498-503. doi: 10.1308/rcsann.2023.0052. Epub 2024 Apr 2.
PubMed 38563077
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery.
- ClinicalTrials.gov ID
- NCT07657039
- Acronym / sponsor ID
- USELESS / 2025-02587-01
- Conditions
- Environment, Waste Output
- Keywords
- Climate change impact, greenhouse gases, environment, Life Cycle Assessment, Single-use materials
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above the age of 18 undergoing stated procedures at Danderyd's hospital.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Climate change impact
Time frame: 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.
4 secondary outcomes
Readmission
Time frame: within 90 days of the performed sugery
Combustible waste
Time frame: All consecutive suergeries for twelve months in each group
Costs
Time frame: All consecutive suergeries for twelve months in each group
Infections
Time frame: Within 90 days of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 36433787Keil M, Viere T, Helms K, Rogowski W. The impact of switching from single-use to reusable healthcare products: a transparency checklist and systematic review of life-cycle assessments. Eur J Public Health. 2023 Feb 3;33(1):56-63. doi: 10.1093/eurpub/ckac174.
- Background8: Ted Schettler, M., Polyvinyl chloride in health care. 2020.
- Background7: WOLF, M.-A., et al., International reference life cycle data system (ILCD) handbook-general guide for life cycle assessment-detailed guidance. 2010.
- Background: PubMed 37054734Rizan C, Lillywhite R, Reed M, Bhutta MF. The carbon footprint of products used in five common surgical operations: identifying contributing products and processes. J R Soc Med. 2023 Jun;116(6):199-213. doi: 10.1177/01410768231166135. Epub 2023 Apr 13.
- Background: PubMed 38713110Grothaus O, Jorgensen A, Maughan G, Anto M, Kazmers NH, Garcia BN. Carbon Footprint of Open Carpal Tunnel Release Surgery Performed in the Procedure Room Versus Operating Room Setting. J Hand Surg Am. 2024 Jun;49(6):576-582. doi: 10.1016/j.jhsa.2024.03.014. Epub 2024 May 6.
- Background: PubMed 32516230Rizan C, Steinbach I, Nicholson R, Lillywhite R, Reed M, Bhutta MF. The Carbon Footprint of Surgical Operations: A Systematic Review. Ann Surg. 2020 Dec;272(6):986-995. doi: 10.1097/SLA.0000000000003951.
- Background3: Boiko, P., et al., Environmental life cycle assessment of surgical versus conservative care pathways for an anterior cruciate ligament injury. Journal of cleaner production, 2025. 535: p. 147136.
- Background: PubMed 39503716Eidmann A, Geiger F, Heinz T, Jakuscheit A, Docheva D, Horas K, Stratos I, Rudert M. Our Impact on Global Warming: A Carbon Footprint Analysis of Orthopaedic Operations. J Bone Joint Surg Am. 2024 Nov 6;106(21):1971-1977. doi: 10.2106/JBJS.24.00212. Epub 2024 Sep 19.
- Background1:Pichler, P.-P., et al., International comparison of health care carbon footprints. Environmental research letters, 2019. 14(6): p. 064004
- Results publication: PubMed 38563077Shah S, Morris H, Thiagarajah S, Gordon A, Sharma S, Haslam P, Garcia J, Ali F. Handling 'carbon footprint' in orthopaedics. Ann R Coll Surg Engl. 2024 Jul;106(6):498-503. doi: 10.1308/rcsann.2023.0052. Epub 2024 Apr 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Environment and Waste Output, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Smith, MD (+46737803594, marianne.smith@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Climate change impact (time frame: Data cwill be collected during 12 months for each group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657039, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.