Clinical trial NCT04670900: Treatment of Olecranon Fractures in the Elderly
Official title: Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Olecranon Fracture
Keywords: Elderly patients
Surgery
Non-operative treatment
Functional outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 76
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized non-inferiority multicenter
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Oxford Elbow Score
timeFrame: 52 weeks
Secondary outcomes:
measure: Range of motion
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 12 weeks
measure: Range of motion
timeFrame: 52 weeks
measure: Elbow extension strength
timeFrame: 6 weeks
measure: Elbow extension strength
timeFrame: 12 weeks
measure: Elbow extension strength
timeFrame: 52 weeks
measure: Elbow satisfaction
timeFrame: 6 weeks
measure: Elbow satisfaction
timeFrame: 12 weeks
measure: Elbow satisfaction
timeFrame: 52 weeks
measure: Complications
timeFrame: Through study period up to 52 weeks.
measure: Number of Reoperations
timeFrame: Through study period up to 52 weeks.
measure: Oxford Elbow Score
timeFrame: 6 weeks
measure: Oxford Elbow Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Baerum Hospital
state: Gjettum
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Trønderlag
city: Arendal
country: Norway
facility: Arendal Hospital
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Grålum
country: Norway
facility: Østfold Hospital Trust
city: Hønefoss
country: Norway
facility: Vestre Viken Hospital Trust
city: Oslo
country: Norway
facility: Orthopedic Center, Ulleval University Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Skien
country: Norway
facility: Telemark Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Tønsberg
country: Norway
facility: Tønsberg Hospital
city: Uppsala
country: Sweden
facility: Akademiska Hospital
Study officials:
affiliation: University of Oslo
name: Frede Frihagen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul.