Scandinavian Olecranon Research in the Elderly

Olecranon Fracture Clinical Trial

Official title:

SCORE Trial - Scandinavian Olecranon Research in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401462
• Other study ID #: SCORE
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Turku University Hospital
• Contact: Ida Rantalaiho, MD
• Phone: +35823135040
• Email: ida.rantalaiho[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Olecranon Fracture

Intervention

Procedure:
• Tension band wiring or plate fixation
Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name

Behavioral:
• Sling or a long-arm plaster
Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.

Locations

Country	Name	City	State
Finland	Hospital Nova	Jyväskylä
Finland	Tampere University Hospital	Tampere
Finland	Turku Central University Hospital	Turku	Varsinais-Suomi
Sweden	Danderyd Hospital	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Turku University Hospital	Copenhagen University Hospital at Herlev, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, University Hospital, Linkoeping

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Disabilities of Arm, Shoulder and Hand (DASH)	Minimum value 0, maximum value 100. Higher scores mean worse outcome.	1 year
Secondary	the Disabilities of Arm, Shoulder and Hand (DASH)	Minimum value 0, maximum value 100. Higher scores mean worse outcome.	3 months
Secondary	Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions	Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.	3 and 12 months
Secondary	Pain, visual analogue scale (VAS)	Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.	3 and 12 months
Secondary	Satisfaction, visual analogue scale (VAS)	Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.	3 and 12 months
Secondary	Elbow X-rays	AP and lateral view.	post-operatively, 2 weeks, 3 and 12 months
Secondary	Range of elbow motion.	The results are reported in degrees. Measurement is performed to the injured arm.	3 and 12 months
Secondary	Comparison of extension strength between injured and healthy elbow.	Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.	12 months
Secondary	Adverse events		up to 12 months