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Casting Techniques for Elbow Fractures
N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- Children 3 to 8 years of age with a diagnosed supracondylar humerus fracture Type 1 (undisplaced).
A) A clear fracture line through the supracondylar region with no displacement or angulation of the distal humerus (including a normal anterior humeral line that intersects the capitellum) OR B) The absence of a clear fracture line but history of an extension injury to the arm AND tenderness at the elbow AND local swelling AND presence of a posterior fat pad on plain radiographs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post fracture
Awards & highlights
Study Summary
This trial compares two ways of treating a type of fracture in kids' arms. One way is with a long arm cast and no clinical or radiographic follow-up. The other way is with a long arm cast and clinical follow-up.
Who is the study for?
This trial is for children aged 3 to 8 with a specific type of elbow fracture (Type 1 supracondylar humerus fracture) that doesn't involve bone displacement. Kids must have symptoms like arm tenderness, swelling, and certain signs on an X-ray. Those with nerve/blood vessel damage, bone diseases, or more severe fractures are excluded.Check my eligibility
What is being tested?
The study compares two treatments for stable elbow fractures in kids: one uses a soft cast without follow-up visits or X-rays; the other uses a traditional full cast with regular check-ups. It aims to see if avoiding clinic visits affects healing and satisfaction.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from the casts, skin irritation or rash under the cast material, and possibly reduced mobility during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 3-8, has a Type 1 supracondylar humerus fracture.
Select...
I have a specific type of elbow injury, with or without a visible fracture but with certain symptoms and X-ray findings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post fracture
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post fracture
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Faces Pain Scale - Revised (FPS-R)
Secondary outcome measures
Is parental satisfaction higher when they are empowered to remove a splint at home and follow a physician directed treatment program?
Is there a difference in range of elbow joint motion between the two groups at 6 months post fracture?
Number of unplanned visits to the hospital or family physician
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"Experimental Treatment1 Intervention
Patients assigned to group 2 will be placed in a long arm cast at 90-100 degrees in neutral rotation. They will be given verbal and written information on the injury, when and how to remove the cast and contact details if there are any concerns.
Since they will not be attending clinical follow-up, an email or telephone survey will be undertaken at 3 weeks and after 6 months. The survey will inquire initially about pain, unplanned returns to the Family Physician and hospital, complications, parent/patient satisfaction and a standardized patient reported outcome score will be taken. Please see attached documentation for the itemized survey questions. The 6 month follow-up will include photographs and an illustrated guide will be given to the families on how to obtain pictures of maximal flexion, extension and the child's carrying angle (attached). Measurements of range of motion from photographs are considered comparable to clinical assessment of range of motion
Group II: Group 1 "Long-arm full cast and routine follow-up"Active Control1 Intervention
Patients assigned to Group 1 will be placed in a long arm cast, at 90-100 degrees in neutral rotation. A referral will then be made to the orthopedic department and the patient reviewed at week 3 with cast removal, clinical assessment and radiographic assessment as determined by the normal practice at the local center.
Find a Location
Who is running the clinical trial?
Queensland Children's Hospital, South BrisbaneUNKNOWN
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child has a fracture affecting their nerves or blood flow.My child, aged 3-8, has a Type 1 supracondylar humerus fracture.My child has a severe elbow fracture.My child was diagnosed with a bone condition that makes them more likely to break bones.I have a specific type of elbow injury, with or without a visible fracture but with certain symptoms and X-ray findings.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2 "Long-arm soft cast and no clinical or radiographic follow-up"
- Group 2: Group 1 "Long-arm full cast and routine follow-up"
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for participants to join this trial at present?
"Clinicaltrials.gov presents evidence that this medical trial is actively accepting patients; the initial post was made on April 1st 2021, and it has been recently updated on October 31st 2022."
Answered by AI
Are there any criteria that a person must meet to join the current clinical trial?
"Candidates aged between 3 and 8 who have suffered a fracture are eligible to partake in this clinical trial. The total number of participants is capped at 52 people."
Answered by AI
Are participants in this trial restricted to adults over eighteen years of age?
"Patients aged 3 - 8 years old are being sought out for this clinical study."
Answered by AI
How many participants has this experiment enrolled thus far?
"Affirmative, data on clinicaltrials.gov reveals that this experiment is recruiting participants at present. This trial was initially posted on April 1st 2021 and last updated on October 31st 2022. The medical study needs to find 52 patients across a single location for enrollment."
Answered by AI
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