Treatment of Olecranon Fractures in the Elderly (CROFT2)

University of Oslo (UIO)

Status: Enrolling

Conditions: Olecranon Fracture

Treatments: Procedure: Tension band wiring or plate fixation; Procedure: Active non-operative treatment with optional plaster cast

Study type: Interventional

Funder types: Other

Identifiers

NCT04670900

REC2018/88

Details and patient eligibility

About

Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.

Full description

Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment

Enrollment: 76 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Displaced olecranon fracture (Mayo 2A and 2B).

Exclusion criteria

• Associated fractures in the coronoid process, radial head or distal humerus.
• Open fracture, Gustilo-Andersen 2 or 3
• Severe cardiopulmonary disease or other medical condition which contraindicates surgery.
• Previous injury to or other condition in the elbow with serious functional impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Operative

Active Comparator group

Description:

Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.

Treatment:

Procedure: Tension band wiring or plate fixation

Non-operative

Experimental group

Description:

Patients will be offered a plaster cast for 1-2 weeks

Treatment:

Procedure: Active non-operative treatment with optional plaster cast