Clinical trial NCT04189185: Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
Official title: Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Olecranon Fracture
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Regionshospitalet Horsens
name: Aarhus University Hospital
name: Regionshospitalet Viborg, Skive
name: Kolding Sygehus
name: Randers Regional Hospital
First posted: 2019-12-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Re-operation
timeFrame: 1 year
Secondary outcomes:
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 1 year
measure: European Quality of life - 5 Dimensions (EQ-5D) questionnaire
timeFrame: 1 year
measure: Range of motion
timeFrame: 1 year
measure: Sick days
timeFrame: 1 year
measure: Non-union
timeFrame: 6 months
measure: Rate of complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Sygehus - Farsø
Study officials:
affiliation: Aalborg University Hostipital
name: Andreas Qvist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University Hospital
name: Andreas Haubjerg Qvist, MD
role: PRINCIPAL_INVESTIGATOR
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