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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.
Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.
Baerum Hospital
Sandvika, Gjettum, Norway
RECRUITINGVestre Viken Hospital Trust
Hønefoss, Norway, Norway
RECRUITINGOxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time frame: 52 weeks
Range of motion
Extension, flexion, rotation
Time frame: 6 weeks
Range of motion
Extension, flexion, rotation
Time frame: 12 weeks
Range of motion
Extension, flexion, rotation measured in degrees total movement for each direction.
Time frame: 52 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.
Time frame: 6 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison.
Time frame: 12 weeks
Elbow extension strength
Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.
Time frame: 52 weeks
Elbow satisfaction
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time frame: 6 weeks
Elbow satisfaction
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St. Olavs Hospital
Trondheim, Trønderlag, Norway
Arendal Hospital
Arendal, Norway
RECRUITINGHaukeland University Hospital
Bergen, Norway
RECRUITINGØstfold Hospital Trust
Grålum, Norway
RECRUITINGOrthopedic Center, Ulleval University Hospital
Oslo, Norway
RECRUITINGDiakonhjemmet Hospital
Oslo, Norway
NOT_YET_RECRUITINGTelemark Hospital
Skien, Norway
RECRUITINGStavanger University Hospital
Stavanger, Norway
RECRUITING...and 2 more locations
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time frame: 12 weeks
Elbow satisfaction
Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Time frame: 52 weeks
Complications
Serious local complications not reoperated.
Time frame: Through study period up to 52 weeks.
Number of Reoperations
Any reoperation
Time frame: Through study period up to 52 weeks.
Oxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time frame: 6 weeks
Oxford Elbow Score
Patient reported 12 item form, 0 (worst) to 100 (best possible score)
Time frame: 12 weeks