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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Fixation of the osteotomized bone with a stable fixation system, in this case, the placement of two steel pins.
Fixation of the osteotomized bone with a stable fixation system, in this case, an obenque configuration
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.
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
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.
Time frame: 12 Months
Number of patients suffering Adverse Events related or not with the medical product within a year
Infection
Time frame: 12 months
Number of patients suffering Adverse Events related or not with the medical product within a year
Complications in the healing process of the surgical wound
Time frame: 12 months
Number of patients suffering: Adverse Events related or not with the medical product within a year
Mechanical complications with the implant
Time frame: 12 months
Number of patients suffering Adverse Events related or not with the medical product, within a year
Reintervention
Time frame: 12 months
Number of patients suffering Adverse Events, related or not with the medical product, within a year
Residual pain
Time frame: 12 months
Number of patients suffering Adverse Events related or not, with the medical product, within a year
Fracture
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.
Measured by Pain leveld (BPI test)
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.
Measured by Mayo Elbow Score Scale (MEPS)
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
Measured by pasive and active movility range
Time frame: 24 months
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