Olecranon Fracture
Conditions
Brief summary
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.
Interventions
Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
BEHAVIORALSling or a long-arm plaster
Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.
Sponsors
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital
University Hospital, Linkoeping
Copenhagen University Hospital at Herlev
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Disabilities of Arm, Shoulder and Hand (DASH) | 1 year | Minimum value 0, maximum value 100. Higher scores mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions | 3 and 12 months | Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability. |
| Pain, visual analogue scale (VAS) | 3 and 12 months | Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain. |
| Satisfaction, visual analogue scale (VAS) | 3 and 12 months | Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation. |
| the Disabilities of Arm, Shoulder and Hand (DASH) | 3 months | Minimum value 0, maximum value 100. Higher scores mean worse outcome. |
| Range of elbow motion. | 3 and 12 months | The results are reported in degrees. Measurement is performed to the injured arm. |
| Comparison of extension strength between injured and healthy elbow. | 12 months | Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight. |
| Adverse events | up to 12 months | — |
| Elbow X-rays | post-operatively, 2 weeks, 3 and 12 months | AP and lateral view. |
Countries
Finland, Sweden
Contacts
Primary ContactIda Rantalaiho, MD
Backup ContactInari Laaksonen, PhD
Outcome results
None listed