Clinical Trial to Evaluate Three Systems of Osteosynthesis for Fixation of Olecranon Osteotomies in Adults
NCT07014358 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2025-06-11
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
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.
Sponsors & Collaborators
-
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2026-06-30
- Completion
- 2027-06-30
Countries
- Spain
Study Locations
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