Tibial FractureFROSTNCT03598530
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures
An observational study of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42, run by AO Clinical Investigation and Publishing Documentation at 15 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fracture, Fracture of the Tibia Type AO/OTA 42
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 4 Apr 2019to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
United States3 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone and affiliated Hospitals
New York, New York, 10016
NYU Langone Jamaica Hospital Medical Center
New York, New York, 11418
Germany3 sites
University Medical Center Mainz
Mainz, 55131
Medical Faculty LMU Munich
Munich, 80539
University Hospital Münster
Münster, 48149
Switzerland2 sites
University Hospital Basel
Basel, 4031
University Hospital Zurich
Zurich, 8091
United Kingdom2 sites
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
Leeds General Infirmary University Hospital
Leeds, LS1 3EX
About this study
Official title: 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
- Being tested
- Surgery
- Keywords
- Fracture fixation, Surgical treatment, Fracture reduction
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Operative, Surgical treatment
Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).
| Study group | Role | What they receive |
|---|---|---|
| Tibial Shaft Fracture | Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks / 6 months / 12 months / 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start4 Apr 2019
- Primary completion17 Mar 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Willem J Metsemakers, Prof., Principal investigator, Department of Trauma Surgery, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598530
- Sponsor's protocol ID
- FROST_RP_v3.0
- Acronym
- FROST
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 33422025
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
- ClinicalTrials.gov ID
- NCT03598530
- Acronym / sponsor ID
- FROST / FROST_RP_v3.0
- Keywords
- Fracture fixation, Surgical treatment, Fracture reduction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jul 2018 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tibial Shaft Fracture | – | Procedure: SurgeryPatients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Operative, Surgical treatmentSurgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation). | Procedure or surgery | Tibial Shaft Fracture |
Primary outcome
Patient-reported outcome
Time frame: 6 weeks / 6 months / 12 months / 36 months
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
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 22 Aug 2025.
- Derived from this study: PubMed 33422025Metsemakers 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.
- Individual participant dataSharing planned: Undecided. 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.
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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. This study is not recruiting at the moment.
Willem J Metsemakers, Prof. principal investigator
Department of Trauma Surgery, UZ Leuven
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Fracture and Fracture of the Tibia Type AO/OTA 42, run by AO Clinical Investigation and Publishing Documentation at 15 sites in 9 countries.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Germany, Switzerland, United Kingdom, Belgium and 4 more countries. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome (time frame: 6 weeks / 6 months / 12 months / 36 months). 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 NCT03598530, which also lists 1 linked publication.
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 22 Aug 2025.