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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (9)

• Number of patients suffering Adverse Events related or not with the medical product within a year [Time frame: 12 months]
• Number of patients suffering Adverse Events related or not with the medical product within a year [Time frame: 12 months]
• Number of patients suffering: Adverse Events related or not with the medical product within a year [Time frame: 12 months]
• Number of patients suffering Adverse Events related or not with the medical product, within a year [Time frame: 12 months]
• Number of patients suffering Adverse Events, related or not with the medical product, within a year [Time frame: 12 months]
• Number of patients suffering Adverse Events related or not, with the medical product, within a year [Time frame: 12 months]
• Efficacy measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product. [Time frame: 24 months]
• Efficacy, measured usimg the evaluation of different scales and tests performed by the patient that altogether provide the needed information about the efficacy of the medical product. [Time frame: 24 months]
• Efficacy, measured usimg the evaluation of different scales and tests performed by the patient, that altogether provide the needed information about the efficacy of the medical product [Time frame: 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 5 centers

• Hospital Mutua Montañesa Santander — Santander
• Clínica CEMTRO — Madrid
• Hospital de Manises — Valencia
• Hospital La Fe — Valencia
• Hospital Universitario de Móstoles — Madrid

Identifiers

NCT: NCT07014358 · FIJAOLE01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗