Clinical trial NCT04401462: Scandinavian Olecranon Research in the Elderly
Official title: SCORE Trial - Scandinavian Olecranon Research in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Olecranon Fracture
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Helsinki University Central Hospital
name: Oulu University Hospital
name: Kuopio University Hospital
name: University Hospital, Linkoeping
name: Copenhagen University Hospital at Herlev
First posted: 2020-05-26
Enrollment: 68
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: 1 year
Secondary outcomes:
measure: the Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: 3 months
measure: Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions
timeFrame: 3 and 12 months
measure: Pain, visual analogue scale (VAS)
timeFrame: 3 and 12 months
measure: Satisfaction, visual analogue scale (VAS)
timeFrame: 3 and 12 months
measure: Elbow X-rays
timeFrame: post-operatively, 2 weeks, 3 and 12 months
measure: Range of elbow motion.
timeFrame: 3 and 12 months
measure: Comparison of extension strength between injured and healthy elbow.
timeFrame: 12 months
measure: Adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku Central University Hospital
state: Varsinais-Suomi
city: Jyväskylä
country: Finland
facility: Hospital Nova
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
References:
citation: Rantalaiho I, Laaksonen I, Launonen AP, Luokkala T, Flinkkila T, Salmela M, Adolfsson L, Olsen B, Isotalo K, Ryosa A, Aarimaa V; SCORE study group. Scandinavian Olecranon Research in the Elderly (SCORE): protocol for a non-inferiority, randomised, controlled, multicentre trial comparing operative and conservative treatment of olecranon fractures in the elderly. BMJ Open. 2022 Jan 31;12(1):e055097. doi: 10.1136/bmjopen-2021-055097.