Trial Outcomes & Findings for Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb (NCT NCT05245617)
NCT ID: NCT05245617
Last Updated: 2026-01-30
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
Up to 18 months from surgery (at device removal)
Results posted on
2026-01-30
Participant Flow
Unit of analysis: implants (i.e. procedures)
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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30 46
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Overall Study
COMPLETED
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29 44
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Overall Study
NOT COMPLETED
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1 2
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Reasons for withdrawal
| Measure |
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.
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JPS Treated Patients
n=30 Participants
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.
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Age, Continuous
Age at surgery
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19.9 years
STANDARD_DEVIATION 6.3 • n=30 Participants
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Age, Continuous
Age at ICF signature
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21.1 years
STANDARD_DEVIATION 6.3 • n=30 Participants
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Sex: Female, Male
Female
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19 Participants
n=30 Participants
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Sex: Female, Male
Male
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11 Participants
n=30 Participants
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Region of Enrollment
Germany
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30 Participants
n=30 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
JPS Treated Patients
n=30 Participants
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.
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|---|---|
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Percentage (%) of Subjects With at Least One Serious/Not Serious Adverse Event Certainly Related or Possibly Related to JPS (ADEs)
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3.3 percentage of subjects
Interval 0.1 to 17.4
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
JPS Treated Patients
n=30 Participants
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.
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|---|---|
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Percentage (%) of Subjects With at Least One Medica Device Deficiencies (MDDs)
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70.0 percentage of subjects
Interval 50.4 to 85.4
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
JPS Treated Patients
n=30 Participants
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.
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|---|---|
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Percentage (%) of Subjects That Reached a Satisfactory Bone Consolidation According to Investigator's Opinion
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96.7 percentage of subjects
Interval 82.6 to 99.9
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SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
JPS Treated Patients
n=27 Participants
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.
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|---|---|
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Percentage (%) of Subjects That Maintained Bone Correction Alignment According to Investigator's Opinion
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96.3 percentage of subjects
Interval 80.9 to 99.9
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Adverse Events
JPS Treated Patients
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
JPS Treated Patients
n=30 participants at risk
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.
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Musculoskeletal and connective tissue disorders
Delayed union, nonunion, malunion
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3.3%
1/30 • Number of events 1 • Adverse events were collected from treatment through the last available follow-up for each patient, with a maximum follow-up duration of up to 18 months, in accordance with site standard practice.
For the retrospective cohort, collect only AEs and MDDs already in medical files from application to device removal. For the prospective cohort, follow clinical practice, CA reporting, and manufacturer instructions before recording AEs/MDDs in the eCRF. In both cohorts, when reporting in eCRF, assess seriousness and device relation. From surgery to removal, record AEs in the patient eCRF as appropriate.
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Surgical and medical procedures
Events caused by anesthesia and surgery
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3.3%
1/30 • Number of events 1 • Adverse events were collected from treatment through the last available follow-up for each patient, with a maximum follow-up duration of up to 18 months, in accordance with site standard practice.
For the retrospective cohort, collect only AEs and MDDs already in medical files from application to device removal. For the prospective cohort, follow clinical practice, CA reporting, and manufacturer instructions before recording AEs/MDDs in the eCRF. In both cohorts, when reporting in eCRF, assess seriousness and device relation. From surgery to removal, record AEs in the patient eCRF as appropriate.
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Injury, poisoning and procedural complications
Loosening of the implant and loss of fixation
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3.3%
1/30 • Number of events 1 • Adverse events were collected from treatment through the last available follow-up for each patient, with a maximum follow-up duration of up to 18 months, in accordance with site standard practice.
For the retrospective cohort, collect only AEs and MDDs already in medical files from application to device removal. For the prospective cohort, follow clinical practice, CA reporting, and manufacturer instructions before recording AEs/MDDs in the eCRF. In both cohorts, when reporting in eCRF, assess seriousness and device relation. From surgery to removal, record AEs in the patient eCRF as appropriate.
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Other adverse events
| Measure |
JPS Treated Patients
n=30 participants at risk
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.
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|---|---|
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Surgical and medical procedures
Events caused by anesthesia and surgery
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13.3%
4/30 • Number of events 6 • Adverse events were collected from treatment through the last available follow-up for each patient, with a maximum follow-up duration of up to 18 months, in accordance with site standard practice.
For the retrospective cohort, collect only AEs and MDDs already in medical files from application to device removal. For the prospective cohort, follow clinical practice, CA reporting, and manufacturer instructions before recording AEs/MDDs in the eCRF. In both cohorts, when reporting in eCRF, assess seriousness and device relation. From surgery to removal, record AEs in the patient eCRF as appropriate.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor and investigator may publish or present study results, submit data to regulatory authorities, and register the study publicly. Co-authors may submit manuscripts/abstracts to the sponsor for review before publication. Sponsor's proposed changes must not affect scientific content. The sponsor's identity and contribution must be disclosed in all publications or presentations.
- Publication restrictions are in place
Restriction type: OTHER