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Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04189185
Enrollment
88
Registered
2019-12-06
Start date
2019-12-05
Completion date
2023-11-20
Last updated
2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Olecranon Fracture

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

Interventions

PROCEDURESuture fixation

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.

Sponsors

Regionshospitalet Horsens
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Regionshospitalet Viborg, Skive
CollaboratorOTHER
Kolding Sygehus
CollaboratorOTHER
Randers Regional Hospital
CollaboratorOTHER
Aalborg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

An envelope deciding the treatment modality is drawn while the patient is anesthetized. Post operative follow-up is performed by blinded assessors. The treatment will be revealed after one year, or if the patient is excluded from the study.

Intervention model description

Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Re-operation1 yearThe rate of re-operation

Secondary

MeasureTime frameDescription
The Disabilities of the Arm, Shoulder and Hand (DASH) Score1 yearPatient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability).
European Quality of life - 5 Dimensions (EQ-5D) questionnaire1 yearPatient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.
Range of motion1 yearRange of motion in elbow
Sick days1 yearNumber of sick days/Return to work
Non-union6 monthsRate of non-union
Rate of complications1 yearRate of complications to the treatment: Infection, nerve damage, delayed wound healing.

Countries

Denmark

Contacts

Primary ContactAndreas Qvist, MD
andreas.christensen@rn.dk+45 9764 3000
Backup ContactBjørn Christensen, MD, PhD
bjornbc@gmail.com+4522449180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026