This study focuses on children with rotational deformities of the long bones (femur and tibia), which can cause gait problems and pain, and are diagnosed via clinical examination and CT imaging.. Other specified acquired deformities of thigh
Conditions
Interventions
Intervention group: The intervention involves surgically implanting a novel rotational growth-guiding plate in children with open growth plates and significant rotational deformities of the femur or t
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 15 Years
Inclusion criteria
Inclusion criteria: Children with open growth plates Presence of rotational deformity in femur or tibia confirmed by clinical examination and CT scan Written informed consent from parents and child to participate in the study Ability to attend regular monthly follow-up visits
Exclusion criteria
Exclusion criteria: Children with closed growth plates or post-skeletal-maturity age Presence of non-rotational bone deformities (e.g., pure valgus or varus deformities) Previous surgery on the affected limb Neuromuscular disorders influencing limb alignment Lack of family cooperation for regular follow-ups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Femoral Anteversion: The rotation of the femoral neck relative to the condylar axis in the axial plane. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tibial Torsion: Axial rotation of the tibia, measured via CT before surgery and after correction. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Mechanical Medial Proximal Tibial Angle (MMPTA): Measures frontal plane alignment of the proximal tibia. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Mechanical Lateral Distal Femoral Angle (MLDFA): Measures frontal plane alignment of the distal femur. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Posterior Distal Femoral Angle (PDFA): Assesses sagittal plane alignment of the distal femur. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Tibial Slope: Inclination of the tibial plateau. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Limb Length: Total length of the affected limb. Timepoint: Baseline (Preoperative), Monthly (till the end of correction), Early Exit (if needed). Method of measurement: Measured using CT-Scan.;Safety/Complications: Includes any surgery- or implant-related complications, such as infection or growth plate injury, assessed during monthly clinical follow-ups. Timepoint: Monthly (till the end of correction). Method of measurement: Clinical Assessment.;Time to Correction: Duration in months required to achieve the desired rotational correction, monitored through monthly clinical assessments and confirmed with imaging. Timepoint: Till the correction of deformity. Method of measurement: Confirmed using CT-Scan. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Nabian
Tehran University of Medical Sciences
Outcome results
None listed