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NOT YET RECRUITING
NCT07014358
PHASE4

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

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

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-06

Completion Date

2027-06

Last Updated

2025-06-11

Healthy Volunteers

No

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.

Locations (5)

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