Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
- Conditions
- Olecranon Fracture
- Interventions
- Procedure: Suture fixation
- Registration Number
- NCT04189185
- Lead Sponsor
- Aalborg University Hospital
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
- Olecranon fracture, Mayo Type 2A
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description K-wire tension band wiring Suture fixation The patient is treated with 1.6 mm k-wires and 1 mm cerclage Suture fixation Suture fixation The fracture is reduced and fixed with 2.0 Orthocord suture.
- Primary Outcome Measures
Name Time Method Re-operation 1 year The rate of re-operation
- Secondary Outcome Measures
Name Time Method Range of motion 1 year Range of motion in elbow
Rate of complications 1 year Rate of complications to the treatment: Infection, nerve damage, delayed wound healing.
The Disabilities of the Arm, Shoulder and Hand (DASH) Score 1 year Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability).
European Quality of life - 5 Dimensions (EQ-5D) questionnaire 1 year Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.
Non-union 6 months Rate of non-union
Sick days 1 year Number of sick days/Return to work
Trial Locations
- Locations (1)
Aalborg Sygehus - Farsø
🇩🇰Aalborg, Denmark