FROST Registry

• Research type

  Research Study

• Full title

  Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (FROST)

• IRAS ID

  296729

• Contact name

  Brigitte Gallo

• Contact email

  brigitte.gallo@aofoundation.org

• Sponsor organisation

  AO Foundation, AO Innovation Translation Center (AO ITC)

• Clinicaltrials.gov Identifier

  NCT03598530

• Duration of Study in the UK

  2 years, 6 months, 31 days

• Research summary

  Tibial fractures are among the most common long-bone injuries.
  Because of the specific anatomical features of the tibia, over 15% of these fractures are classified as open. They represent the most common open long-bone injuries and consequently complications e.g. fracture-related infection (FRI) and compromised fracture healing occur frequently. Despite advances in modern fracture care, treatment of tibial shaft fractures still remains a challenge even in the hands of experienced trauma surgeons.

  There is a limited amount of evidence on how to treat and prevent these complications, that not only reduce the quality of life of patients, but also provoke an enormous burden on overall healthcare costs.
  Therefore, an urgent need exists to generate better evidence to improve care for patients with tibial shaft fractures and consecutively to decrease the financial burden on health care systems.
  
  Patients will be eligible to participate in this registry who suffer from a tibial shaft fracture (AO type 42).
  This registry is a prospective, multicentre case series which is performed in several international clinical institutions.
  Demographic data, medical history, fracture details, treatment details, time to healing and questionnaires will be assessed in one or more visits including baseline, treatment, and additional post-treatment visits up to 36 months after surgical treatment. The type of applied treatment and the schedule of additional post-treatment visits are in accordance of the local standard of care.

  This registry, where patients are treated as per standard of care, offers a unique opportunity to document treatment data on tibial shaft fractures prospectively and to build a database in a systematic way. Such data will be mined to evaluate relationships between treatment and outcome as well as to investigate risk factors associated with complications.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  21/YH/0164

• Date of REC Opinion

  23 Aug 2021

• REC opinion

  Favourable Opinion