Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

N/AActive Not RecruitingNCT03598530

AO Clinical Investigation and Publishing Documentation1,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Tibial Fracture Fracture of the Tibia Type AO/OTA 42

Interventions

SurgeryPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

NYU Langone and affiliated Hospitals

New York, New York, United States

NYU Langone Jamaica Hospital Medical Center

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Department of Trauma Surgery, UZ Leuven

Leuven, Belgium

University Medical Center Mainz

Mainz, Germany

Medical Faculty LMU Munich

Munich, Germany

University Hospital Münster

Münster, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Sengkang General Hospital

Singapore, Singapore

Tygerberg Hospital

Cape Town, South Africa

...and 5 more locations

Outcomes

Primary Outcomes

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

Time frame: 6 weeks / 6 months / 12 months / 36 months