Scandinavian Olecranon Research in the Elderly
ConditionOlecranon Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorTurku University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tension band wiring or plate fixation
Procedure/SurgeryOperative fixation of olecranon fracture with either of the methods mentioned in the intervention name
Sling or a long-arm plaster
BehavioralNon-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Operative groupActive comparator 1 intervention
Group B: Non-operative groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
the Disabilities of Arm, Shoulder and Hand (DASH)
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
Time frame
1 yearSecondary outcomes
1
the Disabilities of Arm, Shoulder and Hand (DASH)
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
Time frame
3 months2
Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.
Time frame
3 and 12 months3
Pain, visual analogue scale (VAS)
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.
Time frame
3 and 12 months4
Satisfaction, visual analogue scale (VAS)
Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.
Time frame
3 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Oulu University Hospital
Collaborator
Kuopio University Hospital
Collaborator
University Hospital, Linkoeping
Collaborator
Copenhagen University Hospital at Herlev
Collaborator
Source ClinicalTrials.gov