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NCT Number: NCT07014358

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

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.

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Key information

Conditions

Olecranon Fracture Arm Injuries Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Ulna Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Mutua Montañesa Santander, Santander, Cantabria, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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.

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.

    Time frame: 12 Months

    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.

Secondary outcomes

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

    Time frame: 12 months

    Infection

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

    Time frame: 12 months

    Complications in the healing process of the surgical wound

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

    Time frame: 12 months

    Mechanical complications with the implant

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

    Time frame: 12 months

    Reintervention

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

    Time frame: 12 months

    Residual pain

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

    Time frame: 12 months

    Fracture

  7. 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

    Measured by Pain leveld (BPI test)

  8. 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

    Measured by Mayo Elbow Score Scale (MEPS)

  9. 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

    Measured by pasive and active movility range

Study contacts

Contact information is provided by the study sponsor or research team.

Miguel Ruiz Ibán, Md

CONTACT

[email protected]

913368208

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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