Olecranon Fracture
Conditions
Keywords
Elderly patients, Surgery, Non-operative treatment, Functional outcome
Brief summary
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.
Detailed 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
Interventions
Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.
PROCEDUREActive non-operative treatment with optional plaster cast
Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Patient instructed not to reveal treatment and to wear long sleeves.
Intervention model description
Randomized non-inferiority multicenter
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Elbow Score | 52 weeks | Patient reported 12 item form, 0 (worst) to 100 (best possible score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elbow extension strength | 6 weeks | Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison. |
| Elbow satisfaction | 6 weeks | Single question: Are you satisfied with your elbow? Yes/Somewhat/No |
| Range of motion | 6 weeks | Extension, flexion, rotation |
| Number of Reoperations | Through study period up to 52 weeks. | Any reoperation |
| Oxford Elbow Score | 6 weeks | Patient reported 12 item form, 0 (worst) to 100 (best possible score) |
| Complications | Through study period up to 52 weeks. | Serious local complications not reoperated. |
Countries
Norway, Sweden
Contacts
Primary ContactFrede Frihagen, PhD
Backup ContactKaare S Midtgaard, MD
Outcome results
None listed