Surgery vs Casting for Children's Elbow Fractures

(COMET Trial)

Overseen By Candace Young, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Other fractures, Metabolic, Neuromuscular, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: 6 weeks

334 Participants Needed

Trial Summary

What is the purpose of this trial?

This protocol describes a multicenter, prospective randomized superiority trial of medial epicondyle fracture treatments comparing functional outcomes between children treated with operative reduction and fixation or non-operative immobilization.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for children's elbow fractures?

Research shows that open reduction and internal fixation (ORIF) can lead to good functional outcomes in complex elbow fractures, as it provides stable fixation. Additionally, ORIF has been effective in managing other types of fractures in children, such as forearm fractures, with excellent results and no major complications. ^{1 2 3 4 5}

Is surgery or casting for children's elbow fractures generally safe?

Open reduction and internal fixation (ORIF) is generally safe, but there can be complications like avascular necrosis (loss of blood supply to bone) in some cases. ORIF tends to have fewer complications compared to other methods in certain fractures, but there is a risk of screw injury in some procedures. ^{2 3 6 7 8}

How does the treatment ORIF differ from other treatments for children's elbow fractures?

ORIF (Open Reduction and Internal Fixation) is a surgical treatment that involves making an incision to directly access and fix the broken bones with plates and screws, which is different from casting or closed reduction where the bones are aligned without surgery. This method is often used when fractures are too severe or unstable to be treated with non-surgical methods, allowing for precise alignment and stabilization of the bones. ^{2 3 5 9 10}

Research Team

Joseph A Janicki

Principal Investigator

Ann and Robert H. Lurie Hospital Chicago

Eligibility Criteria

This trial is for children aged 7-17 with a recent elbow fracture called medial epicondyle fracture. They must be able to take oral medication and follow the treatment plan. Kids with other bone or muscle conditions, additional fractures around the same elbow, or who can't understand the study rules are not eligible.

Inclusion Criteria

Provision of signed and dated informed consent form by parent or legal guardian and signed assent form if participant is older than 12 years

Stated willingness to comply with all study procedures and availability for the duration of the study

My fracture happened less than 10 days ago.

Exclusion Criteria

I have a metabolic or neuromuscular condition.

I have other fractures near the same elbow.

A piece of my elbow bone is trapped in the joint.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either operative reduction with fixation or non-operative immobilization for medial epicondyle fractures

6 weeks

1 visit (in-person) for treatment initiation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 weeks, 3 months, 6 months, and 12 months

12 months

Multiple visits (in-person) at 6 weeks, 3, 6, and 12 months

Long-term Follow-up

Participants are monitored for long-term outcomes, including functional and patient-reported outcomes

36 months

Visits at 24 and 36 months

Treatment Details

Interventions

• cast immobilization
• open reduction and internal fixation (ORIF)

Trial Overview The study compares two ways to treat elbow fractures in kids: surgery (ORIF) versus wearing a cast (non-operative immobilization). It's designed to see which method leads to better arm function after healing.

Participant Groups

Group I: Operative reduction w/ fixation Experimental Treatment 1 Intervention

open reduction and internal fixation (ORIF)

Group II: Non-operative immobilization Active Control 1 Intervention

immobilization in a cast without reduction

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a study of 40 pediatric patients with Monteggia fractures, conservative management through manipulation under anesthesia (MUA) resulted in excellent outcomes for all patients, highlighting its effectiveness for this type of fracture.

For cases where MUA was unsuccessful, open reduction and internal fixation (ORIF) also yielded good results in 8 out of 9 patients, indicating that while conservative treatment is preferred, surgical intervention can be effective when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Monteggia fractures: a single-center study of the management of 40 patients. Leonidou, A., Pagkalos, J., Lepetsos, P., et al.[2022]

In a study of 18 patients with complex distal humeral fractures, the use of a temporary spanning plate in addition to standard open reduction internal fixation (ORIF) significantly improved fracture stability and union rates, especially in challenging cases like comminuted fractures and revision fixations.

At a mean follow-up of 28.3 months, patients showed a good range of motion (mean elbow total arc of motion of 86.3°) and favorable functional outcomes (mean Mayo Elbow Performance Score of 80), indicating that this augmentation technique is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporary spanning plate across the elbow for complex fractures of the distal humerus. Moharram, AN., Mahmoud, M., Lymona, A., et al.[2021]

In a study of 124 children with displaced supracondylar humeral fractures, both open reduction-internal fixation (ORIF) and closed reduction-internal fixation (CRIF) showed similar functional and cosmetic outcomes, with excellent-good results in over 86% of cases.

However, ORIF had significantly shorter operation times (44.2 minutes) and much lower radiation exposure (36.0 seconds of fluoroscopy) compared to CRIF (28.3 minutes and 11.7 seconds), making ORIF a more convenient option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparison of radiation exposure times in the treatment of pediatric supracondylar humeral fractures with open-closed reduction and internal fixation]. Esen, E., Doğramaci, Y., Gültekin, S., et al.[2016]

Open reduction and internal fixation (ORIF) for AO/OTA type 13-C2 and -C3 distal humeral fractures in 23 patients aged over 45 years resulted in good to excellent functional outcomes, with a median Oxford Elbow Score of 42 and a median Mayo Elbow Performance Score of 85 after a minimum follow-up of 2 years.

Despite a notable complication rate, including reoperations in 4 patients, ORIF remains a reliable treatment option, yielding results comparable to total elbow arthroplasty and elbow hemiarthroplasty for similar fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good functional outcomes after open reduction and internal fixation for AO/OTA type 13-C2 and -C3 acute distal humeral fractures in patients aged over 45 years. Al-Hamdani, A., Rasmussen, JV., Olsen, BS.[2021]

In a study of 16 children under 13 years old with 17 forearm fractures, open reduction-internal fixation (ORIF) was performed successfully, showing excellent results with no complications such as infections or delayed unions.

The average follow-up of 12.3 months revealed that all fractures had minimal loss of forearm rotation (< 10 degrees), indicating that ORIF can be a safe and effective treatment option for pediatric forearm fractures when closed reduction is not suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open reduction and internal fixation of forearm fractures in children. Ortega, R., Loder, RT., Louis, DS.[2019]

In a study of 27 children with femoral neck fractures, early anatomical open reduction and internal fixation (ORIF) resulted in a significantly higher rate of anatomical reduction (93.3%) compared to closed reduction and internal fixation (CRIF) which had only 25% anatomical reduction.

ORIF also led to better clinical outcomes, with 93.3% of patients achieving good results, while only 58.3% of those treated with CRIF had good results, indicating that ORIF reduces complications such as avascular necrosis more effectively than CRIF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Displaced fracture of the femoral neck in children: open versus closed reduction. Song, KS.[2022]

In a study of 60 elderly patients with unstable Colles fractures, modified percutaneous K-wire fixation resulted in shorter operation times and less intraoperative blood loss compared to the standard open reduction and internal fixation (ORIF) method.

Patients treated with K-wire fixation reported lower pain levels shortly after surgery, had shorter hospital stays, and incurred lower total hospitalization costs, indicating it is a safe and effective alternative to ORIF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Modified K-wire Fixation with Open Reduction and Internal Fixation (ORIF) for Unstable Colles Fracture in Elderly Patients. Zhang, L., Jiang, H., Zhou, J., et al.[2023]

In a study of 1632 patients undergoing open reduction and internal fixation (ORIF) for jaw trauma or orthognathic surgery, only 0.28% of screws were associated with actual tooth root damage, indicating a low incidence of injury when the procedure is performed carefully.

The study found that while 93.40% of screws did not contact teeth, careful planning and execution can significantly reduce the risk of root injury, making ORIF a generally safe surgical option for managing jaw fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open reduction and internal fixation: Screw injury - Retrospective study. Balaji, P., Balaji, SM.[2018]

A study of 730 patients with open proximal humerus fractures found no significant differences in hospital outcomes between open reduction and internal fixation (ORIF) and shoulder arthroplasty, including complication rates, length of stay, hospital charges, and mortality rates.

Although ORIF patients were generally younger and had lower comorbidity scores, the type of surgical procedure did not predict complications or hospital costs, suggesting both methods are equally viable for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ORIF versus arthroplasty for open proximal humerus fractures: Nationwide Inpatient Sample data between 1998 and 2013. Dixit, A., Cautela, FS., Cooper, CS., et al.[2019]

A case study of a 29-year-old male with both bone forearm fractures demonstrated that a hybrid fixation method using elastic-stable intramedullary nailing (ESIN) and plate fixation is effective for treatment in adults.

The patient achieved satisfactory healing, and the internal fixation was successfully removed 12 months after surgery, indicating the method's efficacy and safety for adult fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid fixation with ESIN for both bone forearm fractures in adults: A case report and literature review. Bai, X., Liu, Z., Chen, W., et al.[2022]

References

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

Pediatric Monteggia fractures: a single-center study of the management of 40 patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Temporary spanning plate across the elbow for complex fractures of the distal humerus. [2021]

3. Turkey pubmed.ncbi.nlm.nih.gov

[Comparison of radiation exposure times in the treatment of pediatric supracondylar humeral fractures with open-closed reduction and internal fixation]. [2016]

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

Good functional outcomes after open reduction and internal fixation for AO/OTA type 13-C2 and -C3 acute distal humeral fractures in patients aged over 45 years. [2021]

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

Open reduction and internal fixation of forearm fractures in children. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Displaced fracture of the femoral neck in children: open versus closed reduction. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Comparison of Modified K-wire Fixation with Open Reduction and Internal Fixation (ORIF) for Unstable Colles Fracture in Elderly Patients. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Open reduction and internal fixation: Screw injury - Retrospective study. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

ORIF versus arthroplasty for open proximal humerus fractures: Nationwide Inpatient Sample data between 1998 and 2013. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Hybrid fixation with ESIN for both bone forearm fractures in adults: A case report and literature review. [2022]