Dual vs. Single Plate Fixation for Collarbone Fractures

(COMPACT Trial)

Overseen By Sara Aman, BSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Open fracture, Pathological fracture, Neurovascular injury, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Dual vs. Single Plate Fixation for Collarbone Fractures?

Research suggests that dual mini-fragment plate fixation may reduce implant-related symptoms and the need for reoperation compared to single plating, while still providing strong support for healing. It is also considered to improve stability in complex fractures and is comparable to other small fragment plating methods in terms of clinical outcomes. ^{1 2 3 4 5}

Is dual plate fixation for collarbone fractures safe?

Research suggests that dual mini-fragment plate fixation for collarbone fractures is generally safe, with the main concern being implant-related symptoms that might require additional surgery. This method aims to reduce implant irritation compared to larger single plates, potentially lowering the need for reoperation. ^{1 6 7 8 9}

How does dual mini-fragment plate fixation differ from single plate fixation for collarbone fractures?

Dual mini-fragment plate fixation uses two smaller plates instead of one larger plate, which may reduce implant-related symptoms and the need for reoperation while still providing strong support for healing the fracture. ^{1 4 7 9 10}

Research Team

Ujash Sheth, MD MSc FRCSC

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

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

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

Exclusion Criteria

Lack of consent

I have severe health problems besides my cancer.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical fixation of midshaft clavicle fractures using either dual mini-fragment plating or single precontoured plating

6 weeks

1 visit (in-person) for surgery

Follow-up

Participants are monitored for safety, effectiveness, and functional outcomes after treatment

24 months

Regular visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months

Long-term follow-up

Participants are assessed for hardware removal and long-term outcomes

24 months

Treatment Details

Interventions

• Dual Mini-fragment Plating (Procedure)
• Single Precontoured Plating (Procedure)

Trial Overview 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.

Participant Groups

Group I: Dual mini-fragment plating Experimental Treatment 1 Intervention

Group II: Single precontoured plating Active Control 1 Intervention

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Canadian Orthopaedic Trauma Society

Collaborator

Trials

5

Recruited

450+

Findings from Research

In a study of 44 patients with midshaft clavicular fractures, the use of dual mini-fragment plate fixation resulted in a significantly lower reoperation rate (0%) compared to single superior plate fixation (29%), indicating better outcomes with the dual plating method.

Both fixation methods achieved a 100% union rate, and while the American Shoulder and Elbow Surgeons (ASES) scores were high for both groups, the difference in scores was not statistically significant, suggesting that dual plating does not compromise functional recovery despite its advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Versus Single-Plate Fixation of Midshaft Clavicular Fractures: A Retrospective Comparative Study. Allis, JB., Cheung, EC., Farrell, ED., et al.[2022]

In a study of 133 patients with diaphyseal clavicle fractures, both precontoured (Pc) and dual mini-fragment (DmF) plating techniques showed similar high rates of union (100% for Pc and 98.3% for DmF), indicating both methods are effective for fracture fixation.

Patients treated with DmF plates had a lower rate of symptomatic implant removal (8%) compared to those with Pc plates (20%), suggesting that DmF may be a safer option regarding post-surgical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Mini-Fragment Plating Is Comparable With Precontoured Small Fragment Plating for Operative Diaphyseal Clavicle Fractures: A Retrospective Cohort Study. DeBaun, MR., Chen, MJ., Campbell, ST., et al.[2021]

In a study of 47 patients with acute mid-shaft clavicle fractures, dual-plate fixation resulted in a 100% bony union rate at 1 year, compared to 93.3% for single-plate fixation, indicating its effectiveness in promoting healing.

At 3 months post-surgery, patients with dual-plate fixation showed better functional recovery compared to those with single-plate fixation, suggesting that dual plating may provide advantages in early rehabilitation without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of comminuted mid-shaft clavicular fractures: Comparison between dual-plate fixation treatment and single-plate fixation. Zhuang, Y., Zhang, Y., Zhou, L., et al.[2021]

Dual mini-fragment plate fixation for displaced midshaft clavicle fractures resulted in high union rates and excellent clinical outcomes, with an average DASH score of 4.0 after one year, indicating good functional recovery.

Biomechanical testing showed that dual plating provides better rigidity in multi-planar bending compared to single locked anterior plating, while being equivalent in axial loading and torsion, suggesting it may be a superior option for fracture stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual mini-fragment plating for midshaft clavicle fractures: a clinical and biomechanical investigation. Prasarn, ML., Meyers, KN., Wilkin, G., et al.[2018]

A systematic review of eight studies involving 278 patients showed that dual plate fixation for displaced midshaft clavicle fractures results in a low implant removal rate of 4.2%, indicating a safer option compared to single plate fixation, which had a 3.9-fold higher removal rate.

The dual plate fixation technique maintains excellent fracture union rates, suggesting it is an effective method for treating these types of fractures without compromising healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and complications after dual plate vs. single plate fixation of displaced mid-shaft clavicle fractures: A systematic review and meta-analysis. You, DZ., Krzyzaniak, H., Kendal, JK., et al.[2022]

In a study of 36 patients with diaphyseal clavicle fractures treated using lower profile dual mini-fragment plates, all fractures healed successfully without loss of reduction or implant failure, indicating high efficacy of this fixation method.

The study reported a low reoperation rate of 15% for symptomatic implant removal, suggesting that the dual mini-fragment plating technique is safe with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of using 2.4/2.4 mm and 2.0/2.4 mm dual mini-fragment plate combinations for fixation of displaced diaphyseal clavicle fractures. Chen, MJ., DeBaun, MR., Salazar, BP., et al.[2021]

In a study using 18 cadaveric clavicle specimens, dual small plate fixation for midshaft clavicle fractures showed biomechanical performance similar to larger single plate techniques, indicating it is a viable alternative for fracture repair.

The dual plating technique, which uses smaller plates, may reduce hardware prominence and irritation, potentially leading to better cosmetic outcomes and lower rates of revision surgery compared to traditional larger plate constructs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Profile Dual Small Plate Fixation Is Biomechanically Similar to Larger Superior or Anteroinferior Single Plate Fixation of Midshaft Clavicle Fractures. Ziegler, CG., Aman, ZS., Storaci, HW., et al.[2020]

Dual plating using mini-fragment plates for midshaft clavicle fractures demonstrated superior axial and bending stiffness compared to a single 3.5-mm plate, indicating a more stable fixation method.

The study found that the optimal dual-plate configuration involved a superior 2.4-mm plate combined with an anterior 2.7-mm plate, which provided significant biomechanical advantages without compromising torsional stiffness or load to failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Different Plate Configurations for Midshaft Clavicle Fracture Fixation: Single Plating Compared with Dual Mini-Fragment Plating. Kitzen, J., Paulson, K., Korley, R., et al.[2022]

Low profile dual plating for midshaft clavicle fractures significantly reduces the overall complication rate (8.1% vs. 22.5%) and re-intervention rate (6.1% vs. 16.1%) compared to single plating, indicating it may be a safer option for patients.

Both techniques achieve similar healing rates, with union rates of 99% for dual plating and 97.4% for single plating, suggesting that dual plating does not compromise healing while offering fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies. Rompen, IF., van de Wall, BJM., van Heijl, M., et al.[2022]

In a study of 256 patients with displaced midshaft clavicular fractures, dual plating significantly reduced the risk of reoperation compared to single plating techniques, with only 1 reoperation in the dual plating group versus 30 in the single plating groups combined.

Dual plating showed an almost 8-fold lower risk of reoperation compared to single plating methods, highlighting its efficacy in minimizing complications such as nonunion and symptomatic hardware.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Mini-Fragment Plate Fixation of Midshaft Clavicle Fractures Reduces Risk of Reoperation Compared With Single-Plate Fixation Techniques. Reddy, RP., Charles, S., Como, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dual Versus Single-Plate Fixation of Midshaft Clavicular Fractures: A Retrospective Comparative Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dual Mini-Fragment Plating Is Comparable With Precontoured Small Fragment Plating for Operative Diaphyseal Clavicle Fractures: A Retrospective Cohort Study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Management of comminuted mid-shaft clavicular fractures: Comparison between dual-plate fixation treatment and single-plate fixation. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Dual mini-fragment plating for midshaft clavicle fractures: a clinical and biomechanical investigation. [2018]

5. India pubmed.ncbi.nlm.nih.gov

Outcomes and complications after dual plate vs. single plate fixation of displaced mid-shaft clavicle fractures: A systematic review and meta-analysis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of using 2.4/2.4 mm and 2.0/2.4 mm dual mini-fragment plate combinations for fixation of displaced diaphyseal clavicle fractures. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Low-Profile Dual Small Plate Fixation Is Biomechanically Similar to Larger Superior or Anteroinferior Single Plate Fixation of Midshaft Clavicle Fractures. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Biomechanical Evaluation of Different Plate Configurations for Midshaft Clavicle Fracture Fixation: Single Plating Compared with Dual Mini-Fragment Plating. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Dual Mini-Fragment Plate Fixation of Midshaft Clavicle Fractures Reduces Risk of Reoperation Compared With Single-Plate Fixation Techniques. [2023]