Periprosthetic Fractures of the Femur Treated by Osteosynthesis

Completed

• Conditions: Periprosthetic Fracture of the Femur
• Interventions: Device: osteosynthesis

• Registration Number: NCT02854566
• Lead Sponsor: Brugmann University Hospital

Brief Summary

Observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015.

The goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of Vancouver fracture.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Consecutive patients having had surgery between 2010 and 2015 within the CHU Brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis).

Exclusion Criteria

• Death during surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
periprosthetic fractures of the femur	osteosynthesis	periprosthetic fractures of the femur treated by osteosynthesis

Primary Outcome Measures

Name	Time	Method
Type of fracture	Up to 2-3 days before surgery (pre-surgery radiography)	Type of fracture according to the Vancouver International Classification
ASA score	During surgery (up to 2 hours)	ASA score
Body Mass Index	Up to 2-3 days before surgery (pre-surgery radiography)	Demographic data
Sex	Up to 2-3 days before surgery (pre-surgery radiography)	Demographic data
Femoral component	Up to 2-3 days before surgery (pre-surgery radiography)	Need for cement within the femur or not
Blood loss	During surgery (up to 2 hours)	Blood loss during surgery
Fracture healing	10 months after surgery	Healing status of the fracture (healed/not healed)
Age	Up to 2-3 days before surgery (pre-surgery radiography)	Demographic data
Prosthesis type	Up to 2-3 days before surgery (pre-surgery radiography)	PTH (total hip prosthesis) or BHP (bipolar hip prosthesis)
Time between 1st surgery and fracture	Up to 2-3 days before surgery (pre-surgery radiography)	Time between 1st surgery and fracture
Mortality rate	10 months after surgery	Mortality rate (any causes)
Complications rate	10 months after surgery	Total complications rate (local + systemic + implant)

Secondary Outcome Measures

Name	Time	Method
Laterality	Up to 2-3 days before surgery (pre-surgery radiography)	Prosthesis on the right or on the left side

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium