Trial Outcomes & Findings for Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities. (NCT NCT05241691)

NCT ID: NCT05241691

Last Updated: 2025-12-18

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 69 participants
• Primary outcome timeframe: an average of 2 years
• Results posted on: 2025-12-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pediatric Patients Treated With Guided Growth Plate System Plus n=69 Participants 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.
Age, Customized Age of partecipants	11.9 years STANDARD_DEVIATION 1.03 • n=47 Participants
Sex: Female, Male Female	26 Participants n=47 Participants
Sex: Female, Male Male	43 Participants n=47 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants
Race (NIH/OMB) Black or African American	0 Participants n=47 Participants
Race (NIH/OMB) White	69 Participants n=47 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants
Region of Enrollment Italy	69 participants n=47 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Pediatric patients treated with Guided Growth Plate System Plus n=69 Participants Non-skeletally mature children with deformities of the long bones of the lower limbs.
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 outcome

Timeframe: 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.

Outcome measures

Measure	Pediatric patients treated with Guided Growth Plate System Plus n=69 Participants Non-skeletally mature children with deformities of the long bones of the lower limbs.
Efficacy Measurement: the Percentage of Subjects That During the Observation Period Have Achieved the Treatment Objectives	68 Participants

Adverse Events

Pediatric patients treated with Guided Growth Plate System Plus

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pediatric patients treated with Guided Growth Plate System Plus n=69 participants at risk 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.
Musculoskeletal and connective tissue disorders Stiffness	2.9% 2/69 • Number of events 2 • from the application of the plate to first post-removal visit: 2 years
Skin and subcutaneous tissue disorders keloid scarring	2.9% 2/69 • Number of events 2 • from the application of the plate to first post-removal visit: 2 years
Skin and subcutaneous tissue disorders hypertrophic scar	2.9% 2/69 • Number of events 2 • from the application of the plate to first post-removal visit: 2 years
Skin and subcutaneous tissue disorders mild medial swelling	1.4% 1/69 • Number of events 1 • from the application of the plate to first post-removal visit: 2 years
Infections and infestations Superficial infection	1.4% 1/69 • Number of events 1 • from the application of the plate to first post-removal visit: 2 years
Musculoskeletal and connective tissue disorders slight limitation of knee extension	1.4% 1/69 • Number of events 1 • from the application of the plate to first post-removal visit: 2 years
Musculoskeletal and connective tissue disorders Pain	2.9% 2/69 • Number of events 2 • from the application of the plate to first post-removal visit: 2 years
Vascular disorders wound bleeding	1.4% 1/69 • Number of events 1 • from the application of the plate to first post-removal visit: 2 years

Additional Information

Clinical Program Manager

Orthofix srl

Phone: 0456719000

Email: danielacangiano@orthofix.it

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place