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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tibial Shaft Fracture | Patients sustaining a tibial shaft fracture (AO/OTA type 42) that requires surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 weeks / 6 months / 12 months / 36 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to bone healing/union | Time elapsed between treatment and union evaluated clinically and radiologically. | 6 weeks / 6 months / 12 months / 36 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Willem J Metsemakers, Prof. | Department of Trauma Surgery, UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone and affiliated Hospitals | New York | New York | 10016 | United States | ||
| NYU Langone Jamaica Hospital Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33422025 | Derived | 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. |
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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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|
| New York |
| New York |
| 11418 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Department of Trauma Surgery, UZ Leuven | Leuven | Belgium |
| University Medical Center Mainz | Mainz | 55131 | Germany |
| Medical Faculty LMU Munich | Munich | 80539 | Germany |
| University Hospital Münster | Münster | 48149 | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Sengkang General Hospital | Singapore | 544886 | Singapore |
| Tygerberg Hospital | Cape Town | 7505 | South Africa |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| University Hospital Basel | Basel | 4031 | Switzerland |
| University Hospital Zurich | Zurich | 8091 | Switzerland |
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| Leeds General Infirmary University Hospital | Leeds | LS1 3EX | United Kingdom |
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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