What side effects are associated with this type of intervention?

Common treatments for collarbone fractures, such as dual mini-fragment plating and single precontoured plating, share several side effects. These include infection, irritation from the hardware, and the potential need for reoperation to remove the implants due to discomfort. Other risks involve non-union or malunion of the fracture, nerve or blood vessel damage, and general surgical risks like complications from anesthesia.

What prior FDA approvals exist?

The FDA has approved various methods for the treatment of collarbone fractures, primarily focusing on mechanical stabilization using plates and screws. Traditional treatments include single precontoured plates, which are designed to fit the natural shape of the clavicle. More recent approaches, such as dual mini-fragment plating, aim to reduce irritation and the need for reoperation by using smaller plates. These methods are part of ongoing research to improve patient outcomes and minimize complications associated with implant removal.

What other types of research exist?

Promising novel alternatives to Dual Mini-Fragment Plating for collarbone fractures include: 1) Bioabsorbable implants, which reduce the need for implant removal surgery; 2) 3D-printed custom plates, tailored to the patient's anatomy for better fit and reduced irritation; 3) Intramedullary fixation, which involves inserting a rod inside the bone to provide stabilization with minimal soft tissue disruption.

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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))

Must not have

Significant medical comorbidities (i.e., ASA grade IV and V)

Concomitant ipsilateral upper extremity fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two surgical methods for fixing broken collarbones in patients with acute displaced fractures. One method uses two smaller plates to reduce irritation, while the other uses a single larger, shaped plate. The goal is to see if the dual plating method results in fewer additional surgeries.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe health problems besides my cancer.

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I have a fracture in the same arm as my breast cancer.

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I have had a fracture due to a disease.

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I have a severe head injury.

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I have a broken bone that is exposed through my skin.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Removal of hardware at two years of follow-up

Secondary study objectives

Adverse events/complications

Functional outcome ASES

Functional outcome DASH

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dual mini-fragment platingExperimental Treatment1 Intervention

Group II: Single precontoured platingActive Control1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for collarbone fractures, such as dual mini-fragment plating and single precontoured plating, work by mechanically stabilizing the fracture site to promote proper bone healing. Dual mini-fragment plating uses two smaller plates to distribute the mechanical load more evenly, which can reduce irritation and the need for reoperation compared to a single larger plate. This method aims to maintain the alignment of bone fragments while minimizing soft tissue disruption. Intramedullary nailing, another common treatment, involves inserting a rod into the bone marrow cavity to stabilize the fracture from within, offering a minimally invasive option with good cosmetic and functional outcomes. These treatments are crucial for patients as they directly impact the healing process, potential complications, and overall recovery experience.

Miniplate osteosynthesis in fracture surgeries: Case series with review of concepts.Plate Versus Intramedullary Fixation Care of Displaced Midshaft Clavicular Fractures: A Meta-Analysis of Prospective Randomized Controlled Trials.Surgical interventions for treating acute fractures or non-union of the middle third of the clavicle.