Retrospective Evaluation of GGPSP'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.

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.

Study Overview

• Status: Completed
• Conditions: Joint Diseases; Genu Varum; Genu Valgum; Knee Deformity; Ankle Deformity; Length Inequality, Leg; Discrepancy Length; Congenital; Deformity of Limb
• Intervention / Treatment: Device: Guided Growth Plate System Plus

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 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 (Actual): 69

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Paediatric patients with open physis (growing children) who have been diagnosed with an angular deformity or discrepancy in length of femur and/or tibia.

Patients must not be over 18 years of age at the time of implantation.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients treated with GGPSP for the correction of femur and/or tibia deformities	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.; Other Names: 8-Plate Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy measurement: the percentage of subjects that during the observation period have achieved the treatment objectives	The treatment objectives are defined as: for hemiepiphysiodesis, angular deformity of the femur and/or partially tibia; or Fully correct in the direction of the standard alignment (mMPTA and mLDFA between 85° and 89°);; for epiphysiodesis, a discrepancy in the length of the femur and/or tibia which is partially or completely correct in relation to the morphologically normal contralateral length of the limb.	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Orthofix s.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pediatric; 8-Plate Plus; hemiepiphysiodesis; epiphysiodesis; guided growth
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Bone Diseases, Developmental; Congenital Abnormalities; Joint Diseases; Genu Varum; Genu Valgum; Leg Length Inequality
• Other Study ID Numbers: OCI_2101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No