Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
NCT ID: NCT05241691
Last Updated: 2025-12-18
Study Results
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View full resultsBasic Information
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COMPLETED
69 participants
OBSERVATIONAL
2021-11-16
2022-01-24
Brief Summary
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For this purpose, a retrospective PMCF study was considered to be the most appropriate study design to obtain the necessary information.
Detailed Description
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* 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
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
17 Years
ALL
No
Sponsors
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Orthofix s.r.l.
INDUSTRY
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OCI_2101
Identifier Type: -
Identifier Source: org_study_id