Strength After Elbow Fractures in the Elderly (STAND-UP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture;Elbow
• Intervention / Treatment: Other: Patient Reported Outcomes; Other: Strength Test

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Kyrsten Butterfield, BSc; Phone Number: 604-553-3247; Email: kyrsten.butterfield@fraserhealth.ca

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Recruiting
      • Royal Columbian Hospital
      • Contact: Kyrsten Butterfield; Phone Number: 604-553-3247; Email: Kyrsten.Butterfield@fraserhealth.ca
      • Principal Investigator: Farhad Moola
      • Sub-Investigator: Trevor Stone
      • Sub-Investigator: Darius Viskontas
      • Sub-Investigator: Kelly Apostle
      • Sub-Investigator: Dory Boyer
      • Sub-Investigator: Bertrand Perey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients for displaced olecranon fractures

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operative; Internal fixation of the displaced olecranon fracture.	Other: Patient Reported Outcomes; Satisfaction, Disabilities of the Shoulder, Arm and Hand; Other: Strength Test; Handheld dynamometer to measure tricep extension
Non Operative; Conservative treatment as determined by the treating surgeon.	Other: Patient Reported Outcomes; Satisfaction, Disabilities of the Shoulder, Arm and Hand; Other: Strength Test; Handheld dynamometer to measure tricep extension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension Strength	Patients will push down on their distal forearm through a hand held dynamometer, to measure tricep extension strength	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arc of Motion	Elbow extension and elbow flexion measured with a goniometer	12 months
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
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
Satisfaction Score	Soccer out of 10, higher the score the better the outcome	6 weeks, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Fraser Orthopaedic Research Society
• Investigators: Principal Investigator: Farhad Moola, PhD, Orthopaedic Surgeon

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Operative; Non Operative
• Additional Relevant MeSH Terms: Elbow Injuries; Wounds and Injuries; Arm Injuries; Elbow Fractures; Fractures, Bone
• Other Study ID Numbers: 2020-147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No