Genu VarumNCT05241691
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
An observational study of Genu Varum and Genu Valgum, run by Orthofix s.r.l. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Genu Varum, Genu Valgum, Joint Diseases
- What is being tested?
- Guided Growth Plate System Plus
- Type of treatment
- Medical device
- How many people
- 69 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2021to 24 Jan 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Clinical Study for the Evaluation of the Safety and Clinical Performance of the Medical Device "Guided Growth Plate System Plus" (GGPSP) for the Treatment of Bone Deformities of the Lower Limbs in Skeletally Not Mature Children.
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.
Read the 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 indicated for the treatment of specific conditions/pathologies between which:
- 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
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity, Ankle Deformity, Length Inequality, Leg
- Being tested
- Guided Growth Plate System Plus
- Keywords
- pediatric, 8-Plate Plus, hemiepiphysiodesis, epiphysiodesis, guided growth
- Medical subject headings
- Genu Varum, Genu Valgum, Joint Diseases, Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Growth Plate System PlusDevice
Also called 8-Plate 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Guided Growth Plate System Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: an average of 2 years
Secondary outcomes (1)
Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives
The treatment objectives are defined as:
- for hemiepiphysiodesis, partially or completely corrected angular deformity of the femur and/or tibia in the direction of standard alignment (normal values of mMPTA and mLDFA between 85° and 89°);
- for epiphysiodesis, discrepancy in the length of the femur and/or tibia partially or completely corrected with respect to the morphologically normal length of the contralateral limb.
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start16 Nov 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix s.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241691
- Sponsor's protocol ID
- OCI_2101
- Status last verified
- Dec 2025
- First submitted
- 2 Feb 2022
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study for the Evaluation of the Safety and Clinical Performance of the Medical Device "Guided Growth Plate System Plus" (GGPSP) for the Treatment of Bone Deformities of the Lower Limbs in Skeletally Not Mature Children.
- ClinicalTrials.gov ID
- NCT05241691
- Acronym / sponsor ID
- OCI_2101
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity, Ankle Deformity, Length Inequality, Leg
- Keywords
- pediatric, 8-Plate Plus, hemiepiphysiodesis, epiphysiodesis, guided growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Orthofix s.r.l.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 indicated for the treatment of specific conditions/pathologies between which:
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients treated with Guided Growth Plate System Plus | – | Device: Guided Growth Plate System PlusPediatric patients treated with Guided Growth Plate System Plus (GGPSP) for the correction of femur and/or tibia deformities |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Growth Plate System PlusAlso: 8-Plate PlusThe implant is thought as one of the surgical options to perform epiphysiodesis and hemiepiphysiodesis minimally invasive, that is without recourse to a corrective osteotomy. | Device | Pediatric patients treated with Guided Growth Plate System Plus |
Primary outcome
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
Time frame: an average of 2 years
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).
1 secondary outcome
Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives
Time frame: an average of 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genu Varum and Genu Valgum, run by Orthofix s.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.