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Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Active, not recruiting
Conditions
Tibial Fracture
Fracture of the Tibia Type AO/OTA 42
Registration Number
NCT03598530
Lead Sponsor
AO Clinical Investigation and Publishing Documentation
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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Patient-reported outcome6 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

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

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

Sengkang General Hospital

🇸🇬

Singapore, Singapore

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NYU Langone and affiliated Hospitals
🇺🇸New York, New York, United States

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