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Dual vs. Single Plate Fixation for Collarbone Fractures (COMPACT Trial)

N/A

Recruiting

Led By Ujash Sheth, MD MSc FRCSC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18 and 65 years of age

A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO/OTA 15.2A/B/C))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average 2 years

Awards & highlights

COMPACT Trial Summary

This trial is studying two ways to fix a broken collarbone. One is with a single plate and the other is with two mini-plates. They want to see if the two mini-plates leads to fewer complications.

Who is the study for?

This trial is for adults aged 18-65 with a completely displaced midshaft fracture of the clavicle that can be fixed with plates and screws. Candidates must have had the injury within the last 28 days, be able to follow up, and give consent. Those with neurovascular injuries, significant other medical issues, open fractures or additional serious injuries are excluded.Check my eligibility

What is being tested?

The study compares two surgical methods for fixing broken collarbones: one using dual mini-fragment plating and another using single precontoured plating. The goal is to see if dual plating leads to fewer repeat surgeries while maintaining similar healing rates and complications.See study design

What are the potential side effects?

Potential side effects may include irritation at the site of implantation leading to possible removal of plates, infection risks from surgery, pain at the fracture site post-operation, and general risks associated with surgical procedures.

COMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have a fully broken collarbone with no touching bone ends.

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My fracture can be fixed with a plate and at least three screws on each end.

COMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Removal of hardware at two years of follow-up

Secondary outcome measures

Adverse events/complications

Functional outcome ASES

Functional outcome DASH

+8 more

COMPACT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dual mini-fragment platingExperimental Treatment1 Intervention

Group II: Single precontoured platingActive Control1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Orthopaedic Trauma SocietyOTHER

4 Previous Clinical Trials

380 Total Patients Enrolled

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,242 Total Patients Enrolled

Ujash Sheth, MD MSc FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Dual Mini-fragment Plating Clinical Trial Eligibility Overview. Trial Name: NCT05231343 — N/A

Collarbone Fracture Research Study Groups: Single precontoured plating, Dual mini-fragment plating

Collarbone Fracture Clinical Trial 2023: Dual Mini-fragment Plating Highlights & Side Effects. Trial Name: NCT05231343 — N/A

Dual Mini-fragment Plating 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231343 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still open slots for this research study?

"Affirmative. The information on clinicaltrials.gov suggests that this trial is currently enrolling patients. It was initially posted on April 4th, 2022 and last modified on the 6th of April. This study seeks 66 participants from a single medical centre."

Answered by AI

Are the age restrictions for this trial limited to those above or below 55 years of age?

"Candidates for this medical trial must be of legal age (18) and under the retirement threshold (65)."

Answered by AI

What is the maximum capacity for participants in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this investigation, which was originally posted on April 4th 2022, is presently searching for subjects. 66 participants will be recruited by one medical establishment."

Answered by AI

Am I a viable candidate to join this investigation?

"This research is enlisting 66 participants who have sustained a clavicle fracture between the ages of 18 and 65. To meet eligibility requirements, patients must possess an AO/OTA 15.2A/B/C completely displaced midshaft break that can be fixed with three screws in each proximal and distal fragment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial

Dr. Ujash Sheth 2022. "Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05231343.