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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Fastening systems by placing two steel pins
  • Fastening systems by a wire in an obenque configuration
  • Fastening systems by the placement of a bolted plate or the placement of a compression screw

Treatment groups

105 Participants
are divided into 3 treatment groups