Pediatric Orthopaedic Implants for Orthopedic Disorders

(Global POISE Trial)

Overseen By Harpreet Chhina, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Metal sensitivity, Inability to follow regimen

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

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of orthopedic implants for children with bone issues such as hip problems, injuries, or limb deformities. These implants stabilize bones, promote proper healing, and prevent future joint issues. The study will monitor the implants' performance over time to ensure they meet new European safety standards. Children who require these implants and can attend follow-up visits are suitable candidates for the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

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

What prior data suggests that this pediatric orthopaedic implant is safe?

Research has shown that pediatric orthopedic implants are generally safe. One study found that removing these implants in children is mostly safe, though there is a risk of bone re-fracture, particularly in areas like the forearm. Another study involving 600 pediatric implants also supported their safety, revealing no major safety issues. These implants play a crucial role in helping bones heal and remain aligned, but it is important to be aware of potential risks, such as the chance of re-fracture in some cases. Overall, evidence suggests that children tolerate these implants well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pediatric orthopedic implants because they offer a tailored approach to treating bone issues in children, which is different from traditional metal plates or screws used in adults. These implants are designed to accommodate a child's growing body, potentially reducing the need for multiple surgeries as the child grows. Additionally, they aim to improve recovery time and comfort compared to current options, making the treatment process less daunting for young patients and their families.

What evidence suggests that this pediatric orthopaedic implant is effective for hip conditions, trauma, and limb deformity?

Studies have shown that pediatric orthopedic implants are crucial for treating conditions like hip issues, injuries, and limb deformities in children. These implants maintain bone alignment, support healing, and protect joints from damage. Although most current implants perform well, they sometimes struggle to adjust to children's growth. Research indicates that new designs are being developed to address this issue. Data collected from using these implants, such as in this trial's longitudinal observational group, also aids in improving them to better suit growing children. Overall, implants play a vital role in successful orthopedic care for children. ^{1 2 4 6 7}

Who Is on the Research Team?

Emily Schaeffer, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

Inclusion Criteria

Informed consent/assent is required

Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly

Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Operative Procedures

Collection of demographic data, medical history, and pre-operative clinical data, including radiographs for the relevant diagnosis

2-4 weeks

Operative Procedures

Collection of operative details, including surgical approach, complications, and device identification

Follow-up

Routine standard of care follow-up visits to collect data on radiographs, device-related adverse events, and implant removals

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Pediatric Orthopaedic Implant

How Is the Trial Designed?

Group I: Longitudinal Observational Group Experimental Treatment 1 Intervention

Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

OrthoPediatrics

Industry Sponsor

Trials

1

Recruited

4,000+

Citations

1. ir.orthopediatrics.com ir.orthopediatrics.com/news-releases/news-release-details/global-poise-study-reaches-milestone-600-orthopedic-implants

Global POISE Study Reaches Milestone of 600 Orthopedic ... The insights generated from this study will inform further refinement of OrthoPediatrics devices to meet the specific needs of growing children ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05361980

Pediatric Orthopaedic Implant Safety & Efficacy Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5995571/

A Growth-Accommodating Implant for Paediatric Applications Existing surgical implants are extremely effective in many cases (2); however, the inability of fixed-size implants to accommodate growth remains a challenge.

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-06264-3

Complication profile and risk patterns following elective ... Data on implant retention duration, type of implant, indication for removal, and post-removal complications were recorded and analyzed. Results.

5. davidsfeldmanmd.com davidsfeldmanmd.com/pdfs/outcomes-analysis-routine-removal-implants.pdf

Outcomes Analysis after Routine Removal of Implants in ... The purpose of this study was to compare preremoval and postremoval outcome measures in children. Twenty-five patients, mean age 11.6 years, completed a pain ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41013524/

Complication profile and risk patterns following elective ... Conclusion: Implant removal in pediatric patients is generally safe; however, the risk of early refracture, especially in the forearm, ...

7. journals.lww.com journals.lww.com/jaaosglobal/fulltext/2022/04000/indications_for_and_risks_associated_with_implant.16.aspx

Indications for and Risks Associated With Implant Removal... Implants used in pediatric trauma patients present a unique set of circumstances regarding indications, risks, timing of implant removal, weight-bearing ...