Scandinavian Olecranon Research in the Elderly

Study Overview
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Brief Summary
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This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.

Official Title
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SCORE Trial - Scandinavian Olecranon Research in the Elderly

Conditions
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Olecranon Fracture

Intervention / Treatment
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* Procedure: Tension band wiring or plate fixation
* Behavioral: Sling or a long-arm plaster


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon Age of patient is 75 years or over at the time of the injury Exclusion Criteria: A delay more than 2 weeks after traumatic event to the day of intervention Mayo type 3 fracture Fracture continuation distal to coronoideus Other acute fracture or nerve damage of the ipsilateral upper limb Old fracture (<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb Open fracture Pathological fracture History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent Patient's inability to understand written and spoken Finnish or Swedish or Danish Patient's denial for participation or cognitive incapability to provide consent Patient physically unfit for surgery

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operative group<br>tension band wiring or plate fixation | Procedure: Tension band wiring or plate fixation<br>* Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name<br>|
| Active Comparator: Non-operative group<br>conservative treatment | Behavioral: Sling or a long-arm plaster<br>* Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Disabilities of Arm, Shoulder and Hand (DASH) | Minimum value 0, maximum value 100. Higher scores mean worse outcome. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Disabilities of Arm, Shoulder and Hand (DASH) | Minimum value 0, maximum value 100. Higher scores mean worse outcome. | 3 months | 
| Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions | Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability. | 3 and 12 months | 
| Pain, visual analogue scale (VAS) | Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain. | 3 and 12 months | 
| Satisfaction, visual analogue scale (VAS) | Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation. | 3 and 12 months | 
| Elbow X-rays | AP and lateral view. | post-operatively, 2 weeks, 3 and 12 months | 
| Range of elbow motion. | The results are reported in degrees. Measurement is performed to the injured arm. | 3 and 12 months | 
| Comparison of extension strength between injured and healthy elbow. | Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight. | 12 months | 
| Adverse events |  | up to 12 months |