Strength After Elbow Fractures in the Elderly

NCT05135949 | Recruiting

• 1 other identifier: 2020-147
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fracture;Elbow

Keywords

Operative; Non Operative

Outcome Measures

Primary Outcomes (1)

• Extension Strength

  Patients will push down on their distal forearm through a hand held dynamometer, to measure tricep extension strength

  12 Months

Secondary Outcomes (4)

• Arc of Motion

  12 months

• Mayo Elbow Performance Index

  12 Months

• Disabilities of the Arm, Shoulder, and Hand

  12 Months

• Satisfaction Score

  6 weeks, 6 months and 12 months

Study Arms (2)

Operative

Internal fixation of the displaced olecranon fracture.

Other: Patient Reported Outcomes; Other: Strength Test

Non Operative

Conservative treatment as determined by the treating surgeon.

Other: Patient Reported Outcomes; Other: Strength Test

Interventions

Patient Reported Outcomes OTHER

Satisfaction, Disabilities of the Shoulder, Arm and Hand

Non Operative; Operative

Strength Test OTHER

Handheld dynamometer to measure tricep extension

Non Operative; Operative

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients for displaced olecranon fractures

You may qualify if:

• ≥65 years of age
• Mayo type II olecranon fracture
• Ambulatory (with or without the use of walking aides)

You may not qualify if:

• Additional injuries to the affected arm or contralateral arm
• Associated nerve injury
• Dementia or cognitive impairment that inhibits the collection of outcome measures
• 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.)
• Injury or previous deficit to the contralateral arm
• Currently enrolled in any other research study involving drugs or medical devices
• Open fractures
• Inability to provide informed consent

Sponsors & Collaborators

• Fraser Orthopaedic Research Society: lead

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

RECRUITING

MeSH Terms

Conditions

Elbow Fractures

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Farhad Moola, PhD

  Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyrsten Butterfield, BSc

CONTACT

604-553-3247; kyrsten.butterfield@fraserhealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 26, 2021
• Study Start: February 22, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)