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

NCT05241691 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2025-12-18

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Orthofix s.r.l.

    lead INDUSTRY

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-16
Primary Completion
2022-01-24
Completion
2022-01-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241691 on ClinicalTrials.gov