New device shows promise for correcting Children's leg deformities
NCT ID NCT05241691
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a medical device used to fix bone deformities in children's legs, like knock-knees or bowlegs. Researchers checked the safety and how well the device worked in 69 children who had already been treated. The goal was to see if the device corrected the bone shape without causing serious problems.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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69 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Jan 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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Up to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Istituto Ortopedico Rizzoli
Bologna, Bologna, 40136, Italy
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