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

Orthofix s.r.l.69 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Such complications shall be understood as: * a serious adverse event expected or not expected * a hardware failure (for example, breaking, detaching or folding of the plate or screws).

Time frame: an average of 2 years

Secondary Outcomes

Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives

The treatment objectives are defined as: * for hemiepiphysiodesis, partially or completely corrected angular deformity of the femur and/or tibia in the direction of standard alignment (normal values of mMPTA and mLDFA between 85° and 89°); * for epiphysiodesis, discrepancy in the length of the femur and/or tibia partially or completely corrected with respect to the morphologically normal length of the contralateral limb.