Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05241691
Status:
COMPLETED
Last Update Posted:
2022-08-26
First Post:
2022-02-02
Brief Title:
Retrospective Evaluation of GGPSPs Safety and Clinical Performance for the Treatment of Lower Limbs Deformities
Sponsor:
Orthofix srl
Organization:
Orthofix srl
Study Overview
Official Title:
Retrospective Clinical Study for the Evaluation of the Safety and Clinical Performance of the Medical Device Guided Growth Plate System Plus GGPSP for the Treatment of Bone Deformities of the Lower Limbs in Skeletally Not Mature Children
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Orthofix is conducting this retrospective Post-market clinical follow up PMCF study to assess the safety and clinical performance of the 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
For this purpose a retrospective PMCF study was considered to be the most appropriate study design to obtain the necessary information
Detailed Description:
GGPSP also named 8 Plate Plus has been developed to redirect long bone growth and is used to correct gradually angular deformity in growing children The device is indicated for the treatment of specific conditionspathologies between which
deformity of the knee femur and or tibia in varumvalgus or flexural extension
deformity of the ankle in varumvalgus or plantar flexion
femur andor tibia length discrepancy
Objectives
The primary objective of the clinical investigation is to assess the safety of the 8 Plate Plus
The secondary objective of the clinical investigation is to assess the clinical benefit of the 8 Plate Plus
The Investigator will include in the study the patients who at the screening visit Visit 0 will meet all the selection criteria It is understood that given the retrospective nature of the study and given that the consent of eligible patients has been collected in advance the patient should not attend the screening visit or subsequent visits In addition during the screening visit Visit 0 the Investigator will collect demographic data and patient history
Subsequently the data of interest relating to the surgery for the application of the plate Visit 1 and the period of treatment will be collected or related to the 2 follow up visits Visits 2 and 3 carried out until or at the removal of the plate plates Visit 4
The course of treatment will be monitored as per clinical practice and will then be collected data that correspond to the follow-up visit planned on average 4 months after removal of the plateplates visit 5
deformity of the knee femur and or tibia in varumvalgus or flexural extension
deformity of the ankle in varumvalgus or plantar flexion
femur andor tibia length discrepancy
Objectives
The primary objective of the clinical investigation is to assess the safety of the 8 Plate Plus
The secondary objective of the clinical investigation is to assess the clinical benefit of the 8 Plate Plus
The Investigator will include in the study the patients who at the screening visit Visit 0 will meet all the selection criteria It is understood that given the retrospective nature of the study and given that the consent of eligible patients has been collected in advance the patient should not attend the screening visit or subsequent visits In addition during the screening visit Visit 0 the Investigator will collect demographic data and patient history
Subsequently the data of interest relating to the surgery for the application of the plate Visit 1 and the period of treatment will be collected or related to the 2 follow up visits Visits 2 and 3 carried out until or at the removal of the plate plates Visit 4
The course of treatment will be monitored as per clinical practice and will then be collected data that correspond to the follow-up visit planned on average 4 months after removal of the plateplates visit 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None