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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05163795
Other study ID # Distal Femur Fractures - SAP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date August 15, 2023

Study information

Verified date May 2024
Source Töölö Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.


Description:

See attached PDF.


Recruitment information / eligibility

Status Completed
Enrollment 299
Est. completion date August 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 110 Years
Eligibility Inclusion Criteria: - Age > 16 years - AO/OTA type A or C distal femur fracture - Fracture located on the metaphyseal area of the distal femur (square method) - Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate - Operative treatment within 1 month after trauma - Operative treatment between years 2009 and 2018 Exclusion Criteria: - Stress fracture - Pathological fracture - An epicondylar or subchondral fracture - A ligament sprain in distal femur - Treatment with a double-plating method or with both plate and nail - Non-surgical treatment and patients who died before the treatment - Treatment with an unconventional plate (other than distal femur plate) - Patients whose follow-up criteria not fulfilled

Study Design


Intervention

Procedure:
Lateral locking plate
Plating of the distal femur fracture with lateral locking plate.

Locations

Country Name City State
Finland Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Töölö Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reoperation Reoperation due to fracture nonunion Within 36 months after the initial trauma
See also
  Status Clinical Trial Phase
Completed NCT05613257 - Distal Targeter vs Free-hand N/A
Completed NCT04340284 - Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion Phase 1/Phase 2
Recruiting NCT05699174 - PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation Phase 3
Recruiting NCT03891888 - Intramedullary Bone Grafting for Open Tibial Shaft Fractures N/A
Recruiting NCT04299022 - Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Recruiting NCT01958502 - Evaluation the Treatment of Nonunion of Long Bone Fracture of Lower Extremities (Femur and Tibia) Using Mononuclear Stem Cells From the Iliac Wing Within a 3-D Tissue Engineered Scaffold Phase 2
Enrolling by invitation NCT03937310 - NGS for Non-unions
Active, not recruiting NCT03129971 - Platelet-rich Plasma Combined With Conventional Surgery in the Treatment of Atrophic Nonunion of Femoral Shaft Fractures N/A

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