Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients

Osteogenesis Imperfecta Clinical Trial

— JTIN  

Official title:

A Single Center Post-market Clinical Follow-up (PMCF) Observational Study Evaluating the Clinical Performance and the Safety Profile of the JuniOrtho™ Telescopic Intramedullary Nail (JTIN) for the Treatment of Pediatric Patients Suffering From Osteogenesis Imperfecta

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05612139
• Other study ID #: OCI_2201
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2024
• Source: Orthofix s.r.l.
• Contact: Edo Knijff
• Phone: (+39) 045 6719 000
• Email: edoknijff[@]orthofix.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.

The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JTIN with Real World Evidence clinical data in a real-life surgical setting, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements. One selected site, experienced in the treatment of pediatric patients with OI, where the usage of JTIN is already part of the normal clinical practice, will participate in this study.

Description:

One selected site, experienced in the treatment of pediatric patients with OI, where the usage of JTIN is already part of the normal clinical practice, will participate in this study. Investigator will screen patients treated (or planned to be treated) with JTIN to verify inclusion and exclusion criteria, to achieve the enrollment of 25 cases. With lost to follow-up percentage estimated at 20%, this will lead to a total of 20 evaluable cases, i.e. 20 implanted JTIN (some patients may contribute for more than one implant). Patients are prospectively and retrospectively enrolled in the study: they may have undergone JTIN implantation from the 1st of January 2022.

Enrolled patients, since this study is non-interventional and observational, will follow the standard medical practice of the site: no requirements regarding the treatment of patients will be imposed on the site or Principal Investigator and the Sponsor will not in any manner influence the treatment decisions. Data of enrolled subjects will be collected for this study up to 1 year from surgery.

The hospital standard care usually, but not exclusively, includes: surgery, discharge and plaster removal visits, and then 3 other follow up visits up to 1 year from surgery (see "Visits and Assessments Schedule"). Visits frequency is estimated as average of the site normal clinical practice, actual visit timing for each patient will be performed according to investigators and hospital staff evaluation.

The patient data will be systematically collected by the investigator in eCRF.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

Inclusion Criteria:

• is in pediatric age (> 18 month and < 18 years) at the time of surgery;

• is skeletally immature;

• has a diagnosis for OI;

• has a regular indication for surgical intervention with JTIN to treat femoral and/or tibial fractures, osteotomies, malunions and non-unions;

• patient and/or legal representative is duly informed and doesn't oppose to participation.

Exclusion Criteria:

• has a medical condition that is a contraindication according to the manufacturer's instruction for use;

• has any conditions that in the Investigator's opinion may interfere with the study execution or due to which the patient should not participate for safety reasons;

• requires the application of, or has already in-situ the application of concomitant devices that cannot be safely removed (except for permitted concomitant devices paragraph);

• is participating in other clinical trials or has taken part in any clinical study in the last 3 months with exception of analytical trials on genetics study related to OI (i.e. studies that do not include an investigational treatment for the patient such as new drugs or other medical devices);

• is likely to be lost to follow up, according to investigator's opinion.

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Device:
• JTIN implantation surgery
The JTIN is a self-extending intramedullary nail (telescopic rod) designed to provide fixation of femoral and/or tibial fractures, osteotomies, malunions and non-unions. The design of the JTIN includes a female and a male component, which are anchored to the proximal cortex and distal epiphysis through screw-type fixation. These two components slide from each other, allowing for extension of the JTIN as the bone structures remodel and patient growth occurs.

Locations

Country	Name	City	State
France	Necker-Enfants Malades Hospital	Paris	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix s.r.l.

Country where clinical trial is conducted

France, 

References & Publications (3)

Azzam KA, Rush ET, Burke BR, Nabower AM, Esposito PW. Mid-term Results of Femoral and Tibial Osteotomies and Fassier-Duval Nailing in Children With Osteogenesis Imperfecta. J Pediatr Orthop. 2018 Jul;38(6):331-336. doi: 10.1097/BPO.0000000000000824. — View Citation

Birke O, Davies N, Latimer M, Little DG, Bellemore M. Experience with the Fassier-Duval telescopic rod: first 24 consecutive cases with a minimum of 1-year follow-up. J Pediatr Orthop. 2011 Jun;31(4):458-64. doi: 10.1097/BPO.0b013e31821bfb50. — View Citation

Novacheck TF, Stout JL, Tervo R. Reliability and validity of the Gillette Functional Assessment Questionnaire as an outcome measure in children with walking disabilities. J Pediatr Orthop. 2000 Jan-Feb;20(1):75-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of procedures with at least one serious/not serious adverse event certainly or possibly related to JTIN	The primary endpoint is measured to evaluate the clinical safety profile of JTIN within the scope of its intended purpose.	1 year
Secondary	Implant survival rate: percentage of not exchanged nails	This endpoint is measured to evaluate the clinical safety of JTIN.	1 year
Secondary	Percentage of procedures with bone union achievement	This endpoint is measured to evaluate the clinical performance of JTIN.	1 year
Secondary	Post-treatment fracture-free survival rate	This endpoint is measured to evaluate the clinical performance of JTIN.	1 year