Pediatric Orthopaedic Implant Safety & Efficacy (Global POISE)

Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program

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

Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy.

Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).

Study Overview

• Status: Recruiting
• Conditions: Hip Dysplasia; Hip Dislocation; Pediatric ALL; Orthopedic Disorder; Hip Disease; Fracture; Implant Complication; Deformity of Limb; Deformity; Bone; Lengthening; Leg; Implant Breakage
• Intervention / Treatment: Device: Pediatric orthopaedic implant

Detailed Description

STUDY PROCEDURES Screening Patients will be screened against basic inclusion/exclusion criteria to see if patients may be appropriate for study participation according to any standard of care assessments available, and where appropriate with the site's REB/IRB screening procedures and local regulatory requirements. If a patient is deemed eligible, data outlined throughout this protocol will be collected, de-identified and entered into a Research Electronic Database Capture (REDCap) system managed at BCCH.

Enrollment Patients will be assigned a sequential, unique study number (subject ID) and de-identified data will be entered in the study database. The center number is designated by the BCCH team for each individual investigational site. The patient number will be in sequential order by the patient screening date starting with 001. Once a patient has been assigned a subject ID, the number will not be reused.

Pre-Operative Procedures Once a patient is identified as eligible for an Implant Safety and Efficacy device report, it will be determined whether that patient is already enrolled in one of the existing condition-specific registries. Should participants be enrolled in a condition-specific registry, demographic data, medical history, preoperative clinical data, including any pre-existing infections at or near the operative site, and data on pre-operative radiographs for the relevant underlying diagnosis will have already been prospectively collected under registry procedures. If a patient has not been previously enrolled in a condition-specific registry, the patient will be offered enrollment in both the condition registry and for the purposes of the Implant Safety and Efficacy device report. Demographic data, medical history, preoperative clinical data and data on pre-operative radiographs for the relevant underlying diagnosis will then be collected retrospectively from the medical record.

Required Data Collection:

Operative details in the source documentation will be collected that provide specific information from the subject's surgery such as surgical approach, complications, and unique device identification (UDI) numbers for the implanted device.

The following data will be collected and entered into the registry:

• Operative data, specific to the technique related to the relevant OrthoPediatrics system/device
• Assessments of any device-related adverse events
• Assessment for other adverse events
• When possible, the UDI number for the device(s) implanted, or information on the device implanted

Follow-up Procedures

Data collected during routine standard of care follow-up visits will be collected as part of this study. The following data will be collected:

• Radiographs obtained during study clinical evaluations to determine bony union, as well as healing or complications
• Device-related adverse events
• Unanticipated device-related serious adverse device effects
• Information on implant removals not related to an adverse event; degree of bony union just prior to implant removal Unscheduled Visits [if or when needed]

The condition-specific registries are designed to capture every visit that occurs, whether scheduled or unscheduled. An unscheduled visit may occur when an adverse event occurs, or when a patient returns outside of the planned interval window. If an unscheduled visit occurs, the following assessments are to be done:

• Assessment of any adverse events related to the device
• Survivorship of the device

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

• Study Contact: Name: Emily Schaeffer, PhD; Phone Number: 604-875-2359; Email: emily.schaeffer@cw.bc.ca
• Study Contact Backup: Name: Harpreet Chhina, PhD; Phone Number: 6008 604-875-2000; Email: hchhina@cw.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • Recruiting
      • BC Children's Hospital
      • Contact: Emily Schaeffer, PhD; Phone Number: 604-875-2359; Email: emily.schaeffer@cw.bc.ca
      • Principal Investigator: Anthony Cooper, FRCSC
      • Principal Investigator: Kishore Mulpuri, FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Anyone who meets the eligibility criteria and is within the age limits listed in the above sections can participate in this study.

Description

Inclusion Criteria:

• 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
• Informed consent/assent is required

Exclusion Criteria:

• Patients with a demonstrated sensitivity to metals
• Patients with an inability to follow a post-operative regimen

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Longitudinal Observational Group; Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.	Device: Pediatric orthopaedic implant; Patient receives a pediatric orthopaedic implant as a part of standard clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device related adverse events	Determine the frequency and severity of device-related adverse events at device-specific end points. All adverse events will be recorded and followed during the study. The frequency and severity of device related adverse events will be analyzed to ensure the device risk profile has not changed.	2 years post implant insertion
Implant survival	Determine the implant survival rate at post-operative end-point: (lack of revision)	2 years post implant insertion
Implant efficacy	Efficacy will be assessed by post-operative clinical and radiographic evaluations at each follow-up end-point to assess bone fixation and/or deformity correction.	2 years post implant insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Outcomes Data Collection Instrument (PODCI)	PODCI - The Pediatric Outcomes Data Collection Instrument (PODCI) was developed by the Pediatric Orthopaedic Society of North America (POSNA) to assess functional health status in children with musculoskeletal disorders. This validated tool consists of seven domains (upper extremity function, transfers and mobility, physical function and sports, comfort, happiness, satisfaction and expectations) and was designed for self-report (adolescents) or parent-report (children or adolescents). Both self-report and parent-report versions will be administered.	2 years post implant insertion
Numeric pain rating scale (NPRS)	The numeric pain rating scale (NPRS) is a subjective, 11-point numerical scale in which respondents self-report their pain on a scale of 0 (no pain at all) to 10 (worst pain imaginable).	2 years post implant insertion
LIMB-Q Kids	LIMB-Q Kids is a new patient reported outcome measure (PROM) for children with lower limb deformities.	2 years post implant insertion

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: OrthoPediatrics
• Investigators: Study Director: Emily Schaeffer, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Congenital Abnormalities; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Musculoskeletal Diseases
• Other Study ID Numbers: H21-03076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes