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

NCT ID: NCT07014358

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fastening systems by placing two steel pins

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Fastening systems by a wire in an obenque configuration

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Fastening systems by the placement of a bolted plate or the placement of a compression screw

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• Understand the purpose of the study and be available for routine hospital visits.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Mutua Montañesa Santander

Santander, Cantabria, Spain

Clínica CEMTRO

Madrid, Madrid, Spain

Hospital de Manises

Valencia, Manises, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital Universitario de Móstoles

Madrid, , Spain

Countries

Spain

Central Contacts

Miguel Ruiz Ibán, Md

Role: CONTACT

drmri@hotmail.com

913368208

Facility Contacts

Ignacio De Rus Aznar

Role: primary

iderus@hotmail.com

Pablo Cañete Pastor

Role: primary

Marta Navarro Bosch

Role: primary

mnavarrob26@yahoo.es

Gia Rodríguez Vaquero

Role: primary

gia.rodriguez@quironsalud.es

Other Identifiers

FIJAOLE01

Identifier Type: -

Identifier Source: org_study_id