Strength After Elbow Fractures in the Elderly

Fracture;Elbow Clinical Trial

— STAND-UP  

Official title:

Strength and Function After Non-operative Treatment of Displaced Olecranon Fractures in the Elderly: Implications of Standing UP From a Seat

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05135949
• Other study ID #: 2020-147
• Status: Recruiting
• Start date: February 22, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: Fraser Orthopaedic Research Society
• Contact: Kyrsten Butterfield, BSc
• Phone: 604-553-3247
• Email: kyrsten.butterfield[@]fraserhealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elderly patients strength and function, specifically the ability to rise from a seat after either operative or non operative treatment of an mayo type 2 olecranon fracture.

Description:

Elderly patients with an olecranon fracture will receive appropriate treatment as determined by the treating surgeon. Patients will then be assessed at 6 weeks, 6 months and 12 months post treatment. Assessments include, range of motion, patient reported outcomes and a strength test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2025
• Est. primary completion date: February 1, 2025
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. =65 years of age

2. Mayo type II olecranon fracture

3. Ambulatory (with or without the use of walking aides)

Exclusion Criteria:

1. Additional injuries to the affected arm or contralateral arm

2. Associated nerve injury

3. Dementia or cognitive impairment that inhibits the collection of outcome measures

4. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)

5. Injury or previous deficit to the contralateral arm

6. Currently enrolled in any other research study involving drugs or medical devices

7. Open fractures

8. Inability to provide informed consent

Related Conditions & MeSH terms

• Elbow Fractures
• Fracture;Elbow
• Fractures, Bone

Intervention

Other:
• Patient Reported Outcomes
Satisfaction, Disabilities of the Shoulder, Arm and Hand
• Strength Test
Handheld dynamometer to measure tricep extension

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Orthopaedic Research Society

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension Strength	Patients will push down on their distal forearm through a hand held dynamometer, to measure tricep extension strength	12 Months
Secondary	Arc of Motion	Elbow extension and elbow flexion measured with a goniometer	12 months
Secondary	Mayo Elbow Performance Index	An instrument used to test the limitations, caused by pathology, of the elbow during activities of daily living. Higher scores indicate a better outcome.	12 Months
Secondary	Disabilities of the Arm, Shoulder, and Hand	A 30 Item questionnaire that measures an individuals' ability to complete tasks, absorb forces and severity of symptoms. Lower scores will indicated better outcomes.Lower scores will indicate better outcomes.	12 Months
Secondary	Satisfaction Score	Soccer out of 10, higher the score the better the outcome	6 weeks, 6 months and 12 months