Humerus Fractures Clinical Trial
Official title:
A Multicenter Randomized Controlled Trial to Investigate the Treatment Outcome of PHILOS Screw Augmentation Compared to PHILOS Without Augmentation in Older Adult Patients With Proximal Humerus Fractures
The primary objective is to compare the mechanical failure risks in the first year after treatment.
Biomechanical tests have shown that augmentation of screws or nails with
polymethylmethacrylate (PMMA) leads to increased mechanical properties of the bone-implant
complex, leading to the assumption that augmentation could reduce mechanical failures in
patients. While a few clinical studies have already been performed with augmented
trochanteric nails in proximal femur fractures, no clinical studies exist with the use of
Proximal Humerus Internal Locking System (PHILOS) and (PMMA) augmentation for the treatment
of fractures in the proximal humerus.
In this study a new standardized technique for augmentation of screw tips using high viscous
PMMA cement (Traumacem V+) with the PHILOS plate will be applied. Fracture treatment with
PHILOS Screw Augmentation will be compared with treatment with PHILOS without augmentation.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02784522 -
Minimally Invasive of Proximal Humerus Fractures With Internal Fixation Improves Shoulder Function in Older Patients
|
N/A | |
| Active, not recruiting |
NCT05143476 -
Serum-Protein-Based Indices for the Progression of Fracture Healing and Nonunion
|