NCT05241691

Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.

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
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Orthofix s.r.l. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Guided Growth Plate System Plus (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 conditions/pathologies between which: * deformity of the knee (femur and / or tibia) in varum/valgus or flexural extension; * deformity of the ankle in varum/valgus or plantar flexion; * femur and/or 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 plate/plates (visit 5).

Conditions

• Genu Varum
• Genu Valgum
• Joint Diseases
• Knee Deformity
• Ankle Deformity
• Length Inequality, Leg
• Discrepancy Length; Congenital
• Deformity of Limb

Interventions

Type	Name	Description
DEVICE	Guided Growth Plate System Plus	The implant is thought as one of the surgical options to perform epiphysiodesis and hemiepiphysiodesis minimally invasive, that is without recourse to a corrective osteotomy.

Timeline

• Start date: 2021-11-16
• Primary completion: 2022-01-24
• Completion: 2022-01-24
• First posted: 2022-02-16
• Last updated: 2025-12-18
• Results posted: 2025-12-18

Locations

1 site across 1 country: Italy