N/A
N=69
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Genu Varum · Genu Valgum · Joint Diseases · Knee Deformity · Ankle Deformity
Bottom Line
View on ClinicalTrials.gov: NCT05241691 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Safety Measurement: Percentage of Subjects Who During the Observation Period Have at Least One Complication Certainly or Potentially Related to the Device in the Studio — 12 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Guided Growth Plate System Plus (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Orthofix s.r.l.
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Measurement: Percentage of Subjects Who During the Observation Period Have at Least One Complication Certainly or Potentially Related to the Device in the Studio |
12 | — |
| SECONDARY Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives |
68 | — |
Summary
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided Growth Plate System (GGPS) from which it differs for small modifications compared to the original design. The purpose of the study is to collect clinical evidence from the use of the device in a representative number of pediatric patients who have already been treated with the device in the study and with at least one control visit post removal of plaque..
For this purpose, a retrospective PMCF study was considered to be the most appropriate study design to obtain the necessary information.
Eligibility Criteria
Inclusion Criteria
- he/she has been diagnosed with an angular deformity or discrepancy in length of femur and/or tibia
- at the time of treatment he/she had not yet reached the age of 18;
- at the time of treatment the growth plates of the treated limbs was not already closed;
- according to the Investigator's judgment, angular deformity and/or length discrepancy had a regular indication for surgical treatment with tensioning plates
- deformity was treated with the 8 Plate Plus , according to the manufacturer's instructions
- the treatment with 8 Plate Plus was completed and the patient had at least one post-removal control of the plate
- clinical patient data for the evaluation of safety and benefit of the device are still available
Exclusion Criteria
- Not treated with 8 Plate Plus to correct upper limb deformities only and not lower limb deformities
- its clinical data are no longer accessible and /or do not allow the evaluation of the safety and benefit of the device under study
- had a medical condition which constitutes a contraindication to treatment with 8 Plate Plus in accordance with the manufacturer's instructions for use;
- at the same time was treated with an unauthorised device which could not be removed without putting the patient's safety at risk.
Data sourced from ClinicalTrials.gov (NCT05241691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.