Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Aalborg University Hospital

Status: Unknown

Conditions: Olecranon Fracture

Treatments: Procedure: Suture fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04189185

20190039

Details and patient eligibility

About

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.

Full 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

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Olecranon fracture, Mayo Type 2A

Exclusion criteria

• Bilateral upper extremity fracture
• Open fracture
• Neurovascular affection
• Injury to ligament, dislocation or subluxation
• Additional upper extremity fracture
• Pathological fracture
• Previous elbow issue
• Fracture more than 14 days old
• Substance abuse
• medical contraindication for surgery
• Previous fracture to the same elbow

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

K-wire tension band wiring

Active Comparator group

Description:

The patient is treated with 1.6 mm k-wires and 1 mm cerclage

Treatment:

Procedure: Suture fixation

Suture fixation

Active Comparator group

Description:

The fracture is reduced and fixed with 2.0 Orthocord suture.

Treatment:

Procedure: Suture fixation