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

NCT05612139 | Completed Results

• 1 other identifier: OCI_2201
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteogenesis Imperfecta

Keywords

nailing; nail; Osteogenesis; pediatric; bone; rare disease; brittle; telescopic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Implant Survival Rate: Percentage of Not Exchanged Nails

  1 year

• Percentage of Procedures With Bone Union Achievement

  1 year

• Post-treatment Fracture-free Survival Rate

  1 year

Study Arms (1)

JTIN treated patients

Pediatric patients, older than 18 months, suffering from osteogenesis imperfecta treated with JTIN telescopic nail

Device: JTIN implantation surgery

Interventions

JTIN implantation surgery DEVICE

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.

JTIN treated patients

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric patients older than 18 months suffering from osteogenesis imperfecta.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (1)

Necker-Enfants Malades Hospital

Paris, Île-de-France Region, 75015, France

Location

Related 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.

  PMID: 27379783 BACKGROUND

• 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.

  PMID: 21572286 BACKGROUND

• 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.

  PMID: 10641694 BACKGROUND

MeSH Terms

Conditions

Osteogenesis Imperfecta; Rare Diseases

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs Operation
• Organization: Orthofix s.r.l.

clinicalaffairs@orthofix.it

+39 045 6719000

Study Officials

• Zagorka Pejin, MD

  Necker-Enfants Malades Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: August 27, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)