Ankle Deformity, Deformity of Limb, Discrepancy Length; Congenital, Genu Valgum, Genu Varum, Joint Diseases, Knee Deformity, Length Inequality, Leg
Conditions
Keywords
pediatric, 8-Plate Plus, hemiepiphysiodesis, epiphysiodesis, guided growth
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 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).
Interventions
DEVICEGuided 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
Orthofix s.r.l.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives | an average of 2 years | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Pediatric Patients Treated With Guided Growth Plate System Plus |
|---|---|
| Age, Customized Age of partecipants | 11.9 years STANDARD_DEVIATION 1.03 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Region of Enrollment Italy | 69 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 12 / 69 |
| serious Total, serious adverse events | 0 / 69 |
Outcome results
Primary
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).
Time frame: an average of 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric patients treated with Guided Growth Plate System Plus | 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 | 12 Participants |
Secondary
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.
Time frame: an average of 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pediatric patients treated with Guided Growth Plate System Plus | Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives | 68 Participants |