Defect, Congenital, Deformity, Trauma
Conditions
Keywords
Femur, Tibia, Congenital, deformity, Plate, Fracture
Brief summary
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of equivalent devices. 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 JPS in a representative population of Patients and users. The rationale of the proposed study is to update and support the pre-market clinical evaluation of the JPS with real-word-evidence clinical data, in order to confirm the benefit/risk ratio of this medical device and to keep the CE mark under Medical Device Regulation (MDR) requirements.
Detailed description
One selected site that is experienced in the treatment of pediatric and adult patients with bone deformities and fractures, where the usage of JPS is already part of the normal clinical practice, will participate in this study. Investigator will provide data for a maximum of 40 JPS implant cases satisfying inclusion and exclusion criteria (predicted drop out rate is 10%) that will contribute for at least 30 cases treated by JPS (note that some patients may contribute for more than one JPS case, according to how many JPS implants were received). For retrospective study cohort, who has previously had JPS implanted and follow-up assessment and JPS removal is done, the investigators shall purely collect clinical data from the medical record of the subjects, concerning the screening criteria, the surgery (MD application) and 4 following events: hospital discharge, first post-application control, bone consolidation assessment and device removal. Data from patients' observation are collected according to the site standard-of-care. Patients, who are prospectively enrolled in the study and have undergone JPS implantation, will have follow-up assessments, as described on Table 10.2, or until patient withdrawal. The patient data will be systematically collected by the investigator in eCRF. As per CIP, the subjects will not undergo additional visit nor non-invasive, invasive or burdensome procedures additional to those performed under the normal clinical practice.
Interventions
DEVICEJuniOrtho™ Plating System™
The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture.
Sponsors
Orthofix s.r.l.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
a patient will be eligible for inclusion in the study if: * had a regular indication for surgical intervention with JPS according to the manufacturer's IFU; * underwent a surgery for bone deformity correction or trauma reconstruction of the lower extremities performed by JPS; * the clinical data registered in her/him patient chart are sufficient to assess the safety and efficacy endpoint of the study; * patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF) \[applicable for the prospective group of patients\] * patient is willing and able to participate in the prospective data collection and comply with the protocol requirements; Note: for the retrospective group of patients to whom all interventions and control visits were already done, a waiver of consent for retrospective data collection to be requested.
Exclusion criteria
a Patient will be excluded from participation in the study if he/she: * had/has a medical condition that is a contraindication according to the manufacturer's instruction for use leaflet; * had/has a concomitant not permitted device which cannot be safely removed; * patient for whom there are other concurrent medical or other conditions that in opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs) | Up to 18 months from surgery (at device removal) | Percentage of subjects who experience at least one adverse event (serious or non-serious) that the investigator judges as certainly or possibly related to the JPS system (ADEs). This outcome is used to assess the safety profile of the JPS system. |
| Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs) | Up to 18 months from surgery (at device removal) | Percentage of subjects who experienced at least one medical device deficiency (MDD) i.e., any inadequacy, malfunction, or nonconformance of the investigational device or its accessories, during the defined observation window. This outcome is used to asses the safety profile of the JPS system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion | Up to 18 months from surgery (at device removal) | Percentage of subjects who achieved satisfactory bone consolidation, as judged by the investigator per protocol-defined criteria, up to the specified assessment time point. This outcome is used to asses the clinical performance of the JPS system. |
| Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion | Up to 18 months from surgery (at device removal) | Percentage of subjects who maintained bone correction alignment, as assessed by the investigator per protocol-defined criteria, up tp the specified follow-up time point. Note: This outcome is calculated only for the subgroup "JPS-Treated Patients for Deformity Correction.", that is the only patients that present a correction alignment. This outcome is used to asses the clinical performance of the JPS system. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORBenedikt Leidinger, MD
Orthopädische Klinik Volmarstein
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| JPS Treated Patients This grup will include all patients with regular indication for JPS: system is intended in pediatric (excluding newborns) and small stature adult patients. Pediatric patients include infants (greater than 1 month to 1 years of age), children (greater than 1 to 12 years of age), adolescents (greater than 12 to 18 years of age) and appropriate adults (where according to investigator assessment, the JPS plates fit the treated bone anatomy).
JuniOrtho™ Plating System™: The patient underwent surgery for the application of JPS for treatment of deformity or traumatic fracture. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | JPS Treated Patients |
|---|---|
| Age, Continuous Age at ICF signature | 21.1 years STANDARD_DEVIATION 6.3 |
| Age, Continuous Age at surgery | 19.9 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Germany | 30 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 2 / 30 |
Outcome results
Primary
Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs)
Percentage of subjects who experienced at least one medical device deficiency (MDD) i.e., any inadequacy, malfunction, or nonconformance of the investigational device or its accessories, during the defined observation window. This outcome is used to asses the safety profile of the JPS system.
Time frame: Up to 18 months from surgery (at device removal)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JPS Treated Patients | Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs) | 70.0 percentage of subjects |
Primary
Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs)
Percentage of subjects who experience at least one adverse event (serious or non-serious) that the investigator judges as certainly or possibly related to the JPS system (ADEs). This outcome is used to assess the safety profile of the JPS system.
Time frame: Up to 18 months from surgery (at device removal)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JPS Treated Patients | Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs) | 3.3 percentage of subjects |
Secondary
Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion
Percentage of subjects who maintained bone correction alignment, as assessed by the investigator per protocol-defined criteria, up tp the specified follow-up time point. Note: This outcome is calculated only for the subgroup JPS-Treated Patients for Deformity Correction., that is the only patients that present a correction alignment. This outcome is used to asses the clinical performance of the JPS system.
Time frame: Up to 18 months from surgery (at device removal)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JPS Treated Patients | Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion | 96.3 percentage of subjects |
Secondary
Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion
Percentage of subjects who achieved satisfactory bone consolidation, as judged by the investigator per protocol-defined criteria, up to the specified assessment time point. This outcome is used to asses the clinical performance of the JPS system.
Time frame: Up to 18 months from surgery (at device removal)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| JPS Treated Patients | Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion | 96.7 percentage of subjects |