Treatment of Olecranon Fractures in the Elderly

Study Overview
=================
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

Official Title
-----------------
Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - A Nordic Multicenter Randomized Trial

Conditions
-----------------
Olecranon Fracture

Intervention / Treatment
-----------------
* Procedure: Tension band wiring or plate fixation
* Procedure: Active non-operative treatment with optional plaster cast


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized non-inferiority multicenter
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative<br>Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate. | Procedure: Tension band wiring or plate fixation<br>* 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.<br>|
| Experimental: Non-operative<br>Patients will be offered a plaster cast for 1-2 weeks | Procedure: Active non-operative treatment with optional plaster cast<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion | Extension, flexion, rotation | 6 weeks | 
| Range of motion | Extension, flexion, rotation | 12 weeks | 
| Range of motion | Extension, flexion, rotation measured in degrees total movement for each direction. | 52 weeks | 
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison. | 6 weeks | 
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. | 12 weeks | 
| Elbow extension strength | Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison. | 52 weeks | 
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 6 weeks | 
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 12 weeks | 
| Elbow satisfaction | Single question: Are you satisfied with your elbow? Yes/Somewhat/No | 52 weeks | 
| Complications | Serious local complications not reoperated. | Through study period up to 52 weeks. | 
| Number of Reoperations | Any reoperation | Through study period up to 52 weeks. | 
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 6 weeks | 
| Oxford Elbow Score | Patient reported 12 item form, 0 (worst) to 100 (best possible score) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly patients, Surgery, Non-operative treatment, Functional outcome