Clinical Trials Directory

Trials / Unknown

UnknownNCT04189185

Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
88 (estimated)
Sponsor
Aalborg University Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Simple displaced olecranon fractures are most often treated with tension band wiring. This is an effective treatment, but the risk of subsequent re-operation is high. The investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.

Detailed description

Background Olecranon fractures are frequent with an incidence of 11.5 per 100.000 people per year. Olecranon fractures are classified according to the Mayo classification in three groups. Type 1A and B are treated conservatively, while comminute fractures of type Mayo 2B and 3B are treated with plate osteosynthesis. The most common type is a simple two part fracture, Mayo type 2A, which represents 74% of all olecranon fractures. The typical treatment of Mayo type 2A fractures is osteosynthesis using k-wires and tension band wiring. This provides adequate fracture healing and good functional results. The use of plate osteosynthesis for Mayo type 2A fractures does not provide functional or health economic benefits compared with operation with tension band wiring. Common for both techniques is a high risk of re-operation due to delayed healing of the surgical wound, and complications arising from the implanted material. Recently, new techniques for Mayo type 2A fractures have been described, in which no metal is implanted. Osteosynthesis is achieved with strong sutures. These techniques have been shown to reduce the high risk of complications leading to re-operation without effecting the functional outcome or fracture healing rate. Hypothesis The investigators hypothesize that suture fixation of Mayo type 2A fractures will decrease the risk of re-operation and provide equal functional outcome compared with tension band wiring. Design Prospective, randomized multicenter study

Conditions

Interventions

TypeNameDescription
PROCEDURESuture fixationThe fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration.

Timeline

Start date
2019-12-05
Primary completion
2021-11-20
Completion
2023-11-20
First posted
2019-12-06
Last updated
2019-12-06

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT04189185. Inclusion in this directory is not an endorsement.