Treatment of Olecranon Fractures in the Elderly

Not Applicable

Recruiting

• Conditions: Olecranon Fracture
• Interventions: Procedure: Tension band wiring or plate fixation; Procedure: Active non-operative treatment with optional plaster cast

• Registration Number: NCT04670900
• Lead Sponsor: Oslo University Hospital

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

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-17
• Study Start: 2021-03-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative	Tension band wiring or plate fixation	Patients will be operated according to Orthopedic Trauma Association (OTA) principles with either tension band wiring or plate fixation with an anatomical precontoured plate.
Non-operative	Active non-operative treatment with optional plaster cast	Patients will be offered a plaster cast for 1-2 weeks

Primary Outcome Measures

Name	Time	Method
Oxford Elbow Score	52 weeks	Patient reported 12 item form, 0 (worst) to 100 (best possible score)

Secondary Outcome Measures

Name	Time	Method
Range of motion	52 weeks	Extension, flexion, rotation measured in degrees total movement for each direction.
Elbow extension strength	52 weeks	Strength measured isometrically on a scale (grams) with elbow 30 degrees flexion. Both arms measured for comparison. arms measured for comparison.
Elbow satisfaction	52 weeks	Single question: Are you satisfied with your elbow? Yes/Somewhat/No
Complications	Through study period up to 52 weeks.	Serious local complications not reoperated.
Number of Reoperations	Through study period up to 52 weeks.	Any reoperation
Oxford Elbow Score	12 weeks	Patient reported 12 item form, 0 (worst) to 100 (best possible score)

Trial Locations

Locations (12)

Østfold Hospital Trust; 🇳🇴 Grålum, Norway

Orthopedic Center, Ulleval University Hospital; 🇳🇴 Oslo, Norway

Baerum Hospital; 🇳🇴 Sandvika, Gjettum, Norway

Vestre Viken Hospital Trust; 🇳🇴 Hønefoss, Norway

Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway

Telemark Hospital; 🇳🇴 Skien, Norway

Stavanger University Hospital; 🇳🇴 Stavanger, Norway

Akademiska Hospital; 🇸🇪 Uppsala, Sweden

Tønsberg Hospital; 🇳🇴 Tønsberg, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Trønderlag, Norway

Arendal Hospital; 🇳🇴 Arendal, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway