Scandinavian Olecranon Research in the Elderly

Not Applicable

Recruiting

• Conditions: Olecranon Fracture
• Interventions: Procedure: Tension band wiring or plate fixation; Behavioral: Sling or a long-arm plaster

• Registration Number: NCT04401462
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative group	Tension band wiring or plate fixation	tension band wiring or plate fixation
Non-operative group	Sling or a long-arm plaster	conservative treatment

Primary Outcome Measures

Name	Time	Method
the Disabilities of Arm, Shoulder and Hand (DASH)	1 year	Minimum value 0, maximum value 100. Higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions	3 and 12 months	Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.
Pain, visual analogue scale (VAS)	3 and 12 months	Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.
Adverse events	up to 12 months
the Disabilities of Arm, Shoulder and Hand (DASH)	3 months	Minimum value 0, maximum value 100. Higher scores mean worse outcome.
Satisfaction, visual analogue scale (VAS)	3 and 12 months	Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.
Range of elbow motion.	3 and 12 months	The results are reported in degrees. Measurement is performed to the injured arm.
Elbow X-rays	post-operatively, 2 weeks, 3 and 12 months	AP and lateral view.
Comparison of extension strength between injured and healthy elbow.	12 months	Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.

Trial Locations

Locations (4)

Hospital Nova; 🇫🇮 Jyväskylä, Finland

Turku Central University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Danderyd Hospital; 🇸🇪 Stockholm, Sweden