Surgery of the elbow joint is often made difficult by the highly constrained nature of the elbow joint. This is why it is often necessary to perform an osteotomy of the olecranon, the proximal part of the ulna, which allows perfect exposure of the entire articular surface. After performing the osteotomy, access to the joint is obtained, the articular problem is solved as appropriate and, upon completion, the osteotomized bone is fixed with a stable fixation system that allows the osteotomy to heal without problems. It is a safe, reproducible procedure that is associated with low associated morbidity. The main problems associated with this procedure are the lack of consolidation of the osteotomy or the need for removal of the osteosynthesis material at a later stage.
Patients who, after receiving information about the design, the purposes of the study, the possible risks that may arise from it and the fact that they may refuse to collaborate at any time, give their written consent to participate in the study.
Be over 18 years of ag
Have an elbow disorder that is to be treated surgically through an olecranon osteotomy approach.
That the olecranon osteotomy is amenable to synthesization with the three proposed systems.
Patients who have undergone ipsilateral elbow surgery.
Presence of ulnar fractures
Patients with an active infection at any site at the time of elbow surgery.
Inability to understand the procedure or information related to the study.
Parallel
Fastening systems by placing two steel pins
DeviceFixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.
Fastening systems by a wire in an obenque configuration
DeviceFixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration
Fastening systems by the placement of a bolted plate or the placement of a compression screw
DeviceFixation of the osteotomized bone with a stable fixation system, in this case, the placement of a bolted plate or the placement of a compression screw.
Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened.
The main evaluation criterion will be the need for reoperation for any cause related to the olecranon osteotomy in the first year of follow-up.
Number of patients suffering Adverse Events related or not with the medical product within a year
Infection
Number of patients suffering Adverse Events related or not with the medical product within a year
Complications in the healing process of the surgical wound
Number of patients suffering: Adverse Events related or not with the medical product within a year
Mechanical complications with the implant
Number of patients suffering Adverse Events related or not with the medical product, within a year
Reintervention
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
