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

NCT05241691 | Completed Results

• 1 other identifier: OCI_2101
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

pediatric; 8-Plate Plus; hemiepiphysiodesis; epiphysiodesis; guided growth

Outcome Measures

Primary Outcomes (1)

• 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).

  an average of 2 years

Secondary Outcomes (1)

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

  an average of 2 years

Study Arms (1)

Pediatric patients treated with Guided Growth Plate System Plus

Pediatric patients treated with Guided Growth Plate System Plus (GGPSP) for the correction of femur and/or tibia deformities

Device: Guided Growth Plate System Plus

Interventions

Guided Growth Plate System Plus DEVICE

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.

Also known as: 8-Plate Plus

Pediatric patients treated with Guided Growth Plate System Plus

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthofix s.r.l.: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Genu Varum; Genu Valgum; Joint Diseases; Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Developmental; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Program Manager
• Organization: Orthofix srl

danielacangiano@orthofix.it

0456719000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 16, 2022
• Study Start: November 16, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: December 18, 2025
• Results First Posted: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)