Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

Fastening systems by placing two steel pins: Fixation 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: Fixation 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: Fixation 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Define which of the three fixarion systems is safer based on the number of patients with each fixation system that need to be reintervened. — 12 Months
  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.

Trial sites (5)

More Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal trials in Spain