NCT07014358

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

Randomized, Patient-blinded, Evaluator-blinded Clinical Trial With Three CE-marked and Approved Devices

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The incidence of these complications is around 4% for the former and 20-50% for the latter. Both complications usually require a second surgical procedure to solve the problem, so the reoperation rates for these procedures are around 40-50%. However, there is discussion in the literature as to the most appropriate fixation system to ensure fracture healing. There are, broadly speaking, three frequently used fixation systems: the placement of two steel pins and a wire in an obenque configuration, the placement of a screwed plate or the placement of a compression screw. It is not clear which is the best fixation system among these three. Biomechanical studies suggest that, from this point of view, all three procedures are adequate. The choice of which is ideal should therefore be based on the ease of use and the complications associated with the procedure, in particular the reoperation rate.There are no clinical trials in the literature comparing these three fixation techniques, so there is a clear lack of knowledge in this field.

Conditions

• Olecranon Fracture

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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
DEVICE	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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

5 sites across 1 country: Spain