The CARBO CARBON Study

NCT07521943 | Recruiting DMC

• 1 other identifier: 2025-07659-02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the environmental impact of two common treatment pathways for hand fractures (metacarpal shaft fractures): surgical and non-surgical management. Healthcare contributes significantly to climate change, and orthopedic surgery in particular generates substantial greenhouse gas emissions. Although surgical treatment is frequently favored for these fractures, it is not always superior to non-surgical treatment, and the difference in environmental impact between these options is not well understood. In this study, researchers will measure and compare the environmental impact of each treatment pathway, from inclusion to twelve months follow-up. This includes environmental impact related to single-use material, medical equipment, energy use, medications, and waste. A Life Cycle Assessment (LCA) will be performed and a mean difference in environmental impact between treatments pathways will be calculates. A Hotspot analysis will also be performed to highlight key sources of environmental impacts. The findings may help guide more sustainable healthcare practices without compromising patient care.

Conditions

Metacarpal Shaft Fractures; Greenhouse Gas Emissions

Keywords

metacarpal fractures; carbon dioxide emissions; LCA analysis; greenhouse gas emissions; carbon dioxide equivalent

Outcome Measures

Primary Outcomes (1)

• Global warming potential

  The primary outccome is global warming potential expressed as the mean carbon dioxide equivalent (CO₂e) emissions between the treatment pathways early rehabilitation without surgery and surgical treatment followed by rehabilitation of metacarpal shaft fractures. Our functional unit is defined as the full treatment pathway from inclusion in the study to 12 months post-treatment

  12 months

Secondary Outcomes (4)

• Ambient air pollution

  12 months

• Water comsumption

  12 months

• Waste

  12 months

• Direct costs

  12 months

Other Outcomes (2)

• Emission hotspots

  12 months

• Environmental impact categories

  12 months

Study Arms (2)

Non operative treatment, early mobilisation

Non-operative treatment by immediate unrestricted mobilization with optional buddy taping or removable splinting for comfort

Procedure: Non-operative treatment

Operative treatment, open reduction and surgical fixation

Operative treatment, open reduction and surgical fixation with plate and screws or screws only, post operative plaster immobilisation followed by rehabilitation

Procedure: Surgical fixation

Interventions

Non-operative treatment PROCEDURE

Non-operative treatment through immediate unrestricted mobilization with optional buddy taping or removable splinting for comfort.

Non operative treatment, early mobilisation

Surgical fixation PROCEDURE

Open reduction and internal fixation with plate and screws or screws only, followed by postoperative imobilisation and rehabilitation.

Operative treatment, open reduction and surgical fixation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The observational cohorts will include all patients enrolled in the CARBO trial, where participants are randomized to either surgical or non-surgical management. The intervention cohort will consist of patients allocated to non-surgical management, whereas the control cohort will comprise patients allocated to surgical management.

You may qualify if:

• Age ≥18 years.
• Access to a valid e-mail.
• Normal bilateral hand function prior to injury.
• Ability and willingness to provide written informed consent
• Single, displaced spiral or oblique diaphyseal fracture of the second to fifth metacarpals with definition of diaphysis as described by AO 2018 (AO/OTA as 77.2-5.2A) (Meinberg et al., 2018).
• Fracture line length at least twice the diameter of the bone at the level of the fracture.
• Fractures with at least 2 mm of radiological displacement and/or malrotation of injured finger compared to uninjured side regardless of fracture displacement.

You may not qualify if:

• The patient is not expected to have difficulty adhering to the study protocol (e.g., due to insufficient language proficiency, dementia, substance abuse, or other reasons).
• The patient does not have an open fracture (Gustilo-Anderson grade \> I) or a pathological fracture.
• The patient does not have an ipsilateral fracture of the upper extremity, polytrauma, or generalized joint dysfunction (e.g., rheumatoid arthritis).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Danderyd's hospital

Stockholm, Stockholm County, 18288, Sweden

RECRUITING

MeSH Terms

Interventions

Surgical Fixation Devices

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Cecilia Mellstrand Navarro, MD, PhD, ass professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Mellstrand Navarro, MD, PhD

CONTACT

+46709280114; cecilia.mellstrand.navarro@ki.se

Elsa Pihl, MD, PhD

CONTACT

+46 8 123 550 00; elsa.pihl@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, ass professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

SE (1)