Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

NCT03598530 | Active Not Recruiting

• 1 other identifier: FROST_RP_v3.0
• Study Type: observational
• Target: 1,000
• Locations: 9 countries
• Sites: 15

Brief Summary

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

Conditions

Tibial Fracture; Fracture of the Tibia Type AO/OTA 42

Keywords

Fracture fixation; Surgical treatment; Fracture reduction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to bone healing/union

  6 weeks / 6 months / 12 months / 36 months

Study Arms (1)

Tibial Shaft Fracture

Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery

Procedure: Surgery

Interventions

Surgery PROCEDURE

Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).

Also known as: Operative, Surgical treatment

Tibial Shaft Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Clinical Investigation and Publishing Documentation: lead
• DePuy Synthes: collaborator

Study Sites (15)

NYU Langone and affiliated Hospitals

New York, New York, 10016, United States

Location

NYU Langone Jamaica Hospital Medical Center

New York, New York, 11418, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Department of Trauma Surgery, UZ Leuven

Leuven, Belgium

Location

University Medical Center Mainz

Mainz, 55131, Germany

Location

Medical Faculty LMU Munich

Munich, 80539, Germany

Location

University Hospital Münster

Münster, 48149, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Sengkang General Hospital

Singapore, 544886, Singapore

Location

Tygerberg Hospital

Cape Town, 7505, South Africa

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

Leeds General Infirmary University Hospital

Leeds, LS1 3EX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33422025 DERIVED

MeSH Terms

Conditions

Tibial Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Willem J Metsemakers, Prof.

  Department of Trauma Surgery, UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 26, 2018
• Study Start: April 4, 2019
• Primary Completion: March 17, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CH (2); GB (2); BE (1); ZA (1); HK (1); US (3); DE (3); KR (1); SG (1)