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

NCT07014358 | Not Yet Recruiting Phase 4

• 1 other identifier: FIJAOLE01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 5

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.

Conditions

Olecranon Fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Months

Secondary Outcomes (9)

• Number of patients suffering Adverse Events related or not with the medical product within a year

  12 months

• Number of patients suffering Adverse Events related or not with the medical product within a year

  12 months

• Number of patients suffering: Adverse Events related or not with the medical product within a year

  12 months

• Number of patients suffering Adverse Events related or not with the medical product, within a year

  12 months

• Number of patients suffering Adverse Events, related or not with the medical product, within a year

  12 months

Study Arms (3)

Fastening systems by placing two steel pins

EXPERIMENTAL

Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.

Device: Fastening systems by placing two steel pins

Fastening systems by a wire in an obenque configuration

EXPERIMENTAL

Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration.

Device: 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

EXPERIMENTAL

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.

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

Interventions

Fastening systems by placing two steel pins DEVICE

Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.

Fastening systems by placing two steel pins

Fastening systems by a wire in an obenque configuration DEVICE

Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration

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 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (5)

Hospital Mutua Montañesa Santander

Santander, Cantabria, 39012, Spain

Location

Clínica CEMTRO

Madrid, Madrid, 28035, Spain

Location

Hospital de Manises

Valencia, Manises, 46940, Spain

Location

Hospital La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario de Móstoles

Madrid, 28935, Spain

Location

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Ulna Fractures; Forearm Injuries; Fractures, Bone

Central Study Contacts

Miguel Ruiz Ibán, Md

CONTACT

913368208; drmri@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

ES (5)