Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Study Overview
=================
Brief 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

Official Title
-----------------
Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Conditions
-----------------
Olecranon Fracture

Intervention / Treatment
-----------------
* Procedure: Suture fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: K-wire tension band wiring<br>The patient is treated with 1.6 mm k-wires and 1 mm cerclage | Procedure: Suture fixation<br>* The 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.<br>|
| Active Comparator: Suture fixation<br>The fracture is reduced and fixed with 2.0 Orthocord suture. | Procedure: Suture fixation<br>* The 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation | The rate of re-operation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability). | 1 year | 
| European Quality of life - 5 Dimensions (EQ-5D) questionnaire | Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories. | 1 year | 
| Range of motion | Range of motion in elbow | 1 year | 
| Sick days | Number of sick days/Return to work | 1 year | 
| Non-union | Rate of non-union | 6 months | 
| Rate of complications | Rate of complications to the treatment: Infection, nerve damage, delayed wound healing. | 1 year |