Status:
COMPLETED
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Lead Sponsor:
Orthofix s.r.l.
Conditions:
Genu Varum
Genu Valgum
Eligibility:
All Genders
Up to 17 years
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 ne...
Detailed Description
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 indicate...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05241691
Start Date
November 16 2021
End Date
January 24 2022
Last Update
December 18 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy, 40136