Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)

Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)

Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required.

Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment

Study Overview

• Status: Active, not recruiting
• Conditions: Tibial Fracture; Fracture of the Tibia Type AO/OTA 42
• Intervention / Treatment: Procedure: Surgery

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Brigitte Gallo, Dr., EMBA; Phone Number: +41 44 200 24 06; Email: brigitte.gallo@aofoundation.org
• Study Contact Backup: Name: Aleksandra Vidakovic; Phone Number: +41 79 948 00 76; Email: aleksandra.vidakovic@aofoundation.org

Study Locations

• Belgium
  • Leuven, Belgium
    • Department of Trauma Surgery, UZ Leuven
• Germany
  • Mainz, Germany, 55131
    • University Medical Center Mainz
  • Munich, Germany, 80539
    • Medical Faculty LMU Munich
  • Münster, Germany, 48149
    • University Hospital Münster
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
• Singapore
  • Singapore, Singapore, 544886
    • Sengkang General Hospital
• South Africa
  • Cape Town, South Africa, 7505
    • Tygerberg Hospital
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Zuerich, Switzerland, 8091
    • University Hospital Zurich
• United Kingdom
  • Coventry, United Kingdom, CV2 2DX
    • University Hospitals Coventry & Warwickshire NHS Trust
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary University Hospital
• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone and affiliated Hospitals
    • New York, New York, United States, 11418
      • NYU Langone Jamaica Hospital Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients older than 18 years old that present a tibial shaft fracture (type 42 according to the AO/OTA Fracture and Dislocation Classification), resulting from a trauma and not caused by a malignancy, that requires surgical treatment.

Description

Inclusion Criteria:

• Age 18 years or older at the time of the injury
• Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care

Exclusion Criteria:

• Pathological fracture caused by malignancy
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tibial Shaft Fracture; Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery	Procedure: Surgery; Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).; Other Names: Surgical treatment; Operative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported outcome	Change in PROMIS Pain interference (v1.0 - Pain Interference 8a) over the the follow-up period Change in PROMIS: Physical function (mobility) (v2.0 - Physical Function 10b) over the the follow-up period	6 weeks / 6 months / 12 months / 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to bone healing/union	Time elapsed between treatment and union evaluated clinically and radiologically.	6 weeks / 6 months / 12 months / 36 months

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Willem J Metsemakers, Prof., Department of Trauma Surgery, UZ Leuven

Publications and helpful links

General Publications

• Metsemakers WJ, Kortram K, Ferreira N, Morgenstern M, Joeris A, Pape HC, Kammerlander C, Konda S, Oh JK, Giannoudis PV, Egol KA, Obremskey WT, Verhofstad MHJ, Raschke M; F.R.O.S.T. Study Group. Fracture-related outcome study for operatively treated tibia shaft fractures (F.R.O.S.T.): registry rationale and design. BMC Musculoskelet Disord. 2021 Jan 9;22(1):57. doi: 10.1186/s12891-020-03930-x.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): November 10, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Surgical treatment; Fracture fixation; Fracture reduction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: FROST_RP_v3.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Registry Steering Committee does accept request to access the data after a minimum of 200 patients have been enrolled and followed-up for at least 1 year.

The Registry Steering Committee will share anonymized data. Charges may apply.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No