Clincosm LogoSign in Get a demo

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

Sponsor
AO Clinical Investigation and Publishing Documentation (Other)
Overall Status
Recruiting
CT.gov ID
NCT03598530
Collaborator
DePuy Synthes (Industry)
1,000
Enrollment
15
Locations
82
Anticipated Duration (Months)
66.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgery

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures (FROST)
Actual Study Start Date :
Mar 1, 2019
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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:
  • Operative
  • Surgical treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient-reported outcome [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

    Other Outcome Measures

    1. Time to bone healing/union [6 weeks / 6 months / 12 months / 36 months]

      Time elapsed between treatment and union evaluated clinically and radiologically.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone and affiliated Hospitals New York New York United States 10016
    2 NYU Langone Jamaica Hospital Medical Center New York New York United States 11418
    3 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    4 Department of Trauma Surgery, UZ Leuven Leuven Belgium
    5 University Medical Center Mainz Mainz Germany 55131
    6 Medical Faculty LMU Munich Munich Germany 80539
    7 University Hospital Münster Münster Germany 48149
    8 Queen Mary Hospital Hong Kong Hong Kong
    9 Korea University Guro Hospital Seoul Korea, Republic of 08308
    10 Sengkang General Hospital Singapore Singapore 544886
    11 Tygerberg Hospital Cape Town South Africa 7505
    12 University Hospital Basel Basel Switzerland 4031
    13 University Hospital Zurich Zuerich Switzerland 8091
    14 University Hospitals Coventry & Warwickshire NHS Trust Coventry United Kingdom CV2 2DX
    15 Leeds General Infirmary University Hospital Leeds United Kingdom LS1 3EX

    Sponsors and Collaborators

    • AO Clinical Investigation and Publishing Documentation
    • DePuy Synthes

    Investigators

    • Principal Investigator: Willem J Metsemakers, Prof., Department of Trauma Surgery, UZ Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AO Clinical Investigation and Publishing Documentation
    ClinicalTrials.gov Identifier:
    NCT03598530
    Other Study ID Numbers:
    • FROST_RP_v2.0
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AO Clinical Investigation and Publishing Documentation
    Fracture fixation
    Surgical treatment
    Fracture reduction
    Additional relevant MeSH terms:
    Fractures, Bone
    Tibial Fractures

    Study Results

    No Results Posted as of Jul 20, 2022