Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Active, not recruiting

• Conditions: Tibial Fracture; Fracture of the Tibia Type AO/OTA 42
• Interventions: Procedure: Surgery

• 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

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2019-04-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-03-10
• Study Completion: 2025-12-31

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

Arm && Interventions

Group	Intervention	Description
Tibial Shaft Fracture	Surgery	Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Sengkang General Hospital; 🇸🇬 Singapore, Singapore

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Zurich; 🇨🇭 Zuerich, Switzerland

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University Hospital Münster; 🇩🇪 Münster, Germany

NYU Langone Jamaica Hospital Medical Center; 🇺🇸 New York, New York, United States

University Medical Center Mainz; 🇩🇪 Mainz, Germany

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

Medical Faculty LMU Munich; 🇩🇪 Munich, Germany

Department of Trauma Surgery, UZ Leuven; 🇧🇪 Leuven, Belgium

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Leeds General Infirmary University Hospital; 🇬🇧 Leeds, United Kingdom

Tygerberg Hospital; 🇿🇦 Cape Town, South Africa

University Hospitals Coventry & Warwickshire NHS Trust; 🇬🇧 Coventry, United Kingdom

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong