Dual vs. Single Plate Fixation for Collarbone Fractures

(COMPACT Trial)

Overseen By Sara Aman, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using two smaller plates (Dual Mini-fragment Plating) to fix a broken collarbone is more effective than using one larger plate (Single Precontoured Plating). The researchers seek to find out if the smaller plates cause less irritation and require fewer repeat surgeries while still promoting proper bone healing. Suitable participants have a collarbone fracture with non-touching bone pieces and are considering surgical repair. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed promising results using two small plates for collarbone fractures. This method required a smaller surgical cut and posed a low risk of hardware protrusion. It also had a low likelihood of needing additional surgery or improper bone healing.

Research on a single pre-shaped plate found it to be a safe option as well. It often results in good healing with a low risk of the bone not joining correctly or healing poorly. However, the plate may cause discomfort or irritation.

Both treatments have proven effective and generally safe, each with its own advantages and disadvantages. Participants should consider these findings when deciding about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring dual mini-fragment plating and single precontoured plating for collarbone fractures because these methods offer new approaches to fixation compared to traditional single plate options. Dual mini-fragment plating involves using two smaller plates, which might provide more stability and reduce the risk of implant failure, potentially leading to faster recovery times. Single precontoured plating, on the other hand, utilizes plates pre-shaped to fit the natural curve of the collarbone, which can improve comfort and alignment, enhancing the healing process. These innovative techniques may offer better outcomes for patients with collarbone fractures by addressing limitations of current standard treatments.

What evidence suggests that this trial's treatments could be effective for collarbone fractures?

This trial will compare dual mini-fragment plating with single precontoured plating for collarbone fractures. Research has shown that using two small plates, which participants in one arm of this trial may receive, might lead to fewer cases where the plates need removal. Studies also indicate that this method results in fewer issues like plates protruding, without affecting fracture healing. Patients have reported good results, experiencing less discomfort and having smaller surgical scars. Conversely, using a single pre-shaped plate, which participants in another arm of this trial may receive, has shown excellent long-term results and heals well. However, it might lead to more cases where the plate requires removal due to irritation. Both methods are effective, but using two plates might slightly reduce the need for additional surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Ujash Sheth, MD MSc FRCSC

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dual Mini-fragment Plating
• Single Precontoured Plating

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10772796/

Clinical Outcomes of Double Mini-Plating Compared with a ... Double mini-plating of diaphyseal clavicular fractures could result in a smaller surgical incision and a lower rate of prominence without affecting fixation ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1058274624009376/pdf

Dual mini-fragment plate fixation of midshaft clavicle ... The purpose of this study was to compare the complications and patient-reported outcomes of dual mini-fragment plate fixation to nonoperative management for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8079453/

Outcomes and complications after dual plate vs. single plate ... Results from this systematic review demonstrate that ORIF of displaced midshaft clavicle fractures using a dual plate fixation technique is a viable option.

4. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(24)00937-6/abstract

Dual mini-fragment plate fixation of midshaft clavicle ... The primary outcomes were union complications including nonunion, delayed union, and symptomatic malunion. Secondary outcomes were patient- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S026800332200064X

Low-profile dual mini-fragment plating of diaphyseal ... Low-profile dual mini-fragment plate constructs have revealed lower implant removal rates following fixation of diaphyseal clavicle fractures.

6. jshoulderelbow.org jshoulderelbow.org/article/S1058-2746(23)00668-7/fulltext

New generation of superior single plating vs. low-profile ... On the other hand, minifragment plates in dual plating mode have demonstrated promising clinical results. The aim of the current study was to ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37849249/

Dual Mini-Fragment Plate Fixation of Midshaft Clavicle ... Dual-plate fixation represents an excellent treatment for displaced midshaft clavicular fractures, with low rates of nonunion and reoperation.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138320300140

Safety and efficacy of using 2.4/2.4 mm and 2.0 ... Dual plating, using 2.4/2.4 mm and 2.0/2.4 mm mini-fragment plate combinations, creates a stable construct that reliably maintains fracture reduction to healing ...