Status:
COMPLETED
Comparative Evaluation of Minimally Invasive "tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures
Lead Sponsor:
Poitiers University Hospital
Conditions:
Schatzker Type 2 or 3 Tibial Plateau Fracture
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in France. 50% of these s...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Patients with a Schatzker type 2 or 3 tibial plateau fracture (compression with or without split) demonstrated on CT-scan and located in the lateral or medial condyle of tibia.
- Patients with fractures caused by trauma.
- Patients with fractures 10 days old maximum.
- Understand and accept the constraints of the study.
- Be a beneficiary or affiliated member of a Health Insurance plan.
- Give written consent for the study after having received clear information.
Exclusion
- Age \< 18 years old.
- Patients with fractures resulting from osteolysis.
- Patients with open fractures.
- Patients with fractures more than 10 days old.
- Patients with concomitant fracture(s) or condition(s) during the trauma reducing the range of motion.
- Patients unable to walk before the injury.
- History of sepsis in the injured knee.
- Contraindications to anesthesia, contrast agent, medical devices or cement.
- History of hypersensitivity reactions to contrast media, bone filler or metal.
- Patients with a degenerative joint disease (polyarthritis, etc.).
- Absence of signature of the informed consent form.
- Patients not covered by French national health insurance.
- Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients in an emergency setting.
Key Trial Info
Start Date :
October 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03444779
Start Date
October 26 2018
End Date
November 14 2024
Last Update
December 2 2024
Active Locations (12)
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1
CHU d'Amiens
Amiens, France
2
CHU Angers
Angers, France
3
AP-HP / Hopital Ambroise Paré
Boulogne-Billancourt, France
4
CHU de Brest
Brest, France