Plate vs. Screw for Guided Growth in Coronal Knee Deformities

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-16
SponsorAssiut University

About this trial

The goal of this clinical trial is to compare two surgical techniques, Tension Band Plate (TBP) and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS), in children with coronal angular knee deformities.

The main questions it aims to answer are:

* Which technique provides better correction of coronal knee deformities? * Are there differences in complication rates or recovery times between TBP and PETS?

Participants will:

* Undergo either TBP or PETS surgery for knee deformity correction. * Attend follow-up visits for radiographic and clinical evaluations.

Researchers will compare TBP and PETS groups to see if one method leads to better deformity correction and fewer complications.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children and adolescents beyond the age of physiological varus/valgus correction (i.e., typically ≥4 years for genu varum and ≥7 years for genu valgum) with Mechanical Axis Deviation (MAD) in lower limbs and abnormal joint orientation angles, in the coronal plane either femoral or tibial.

Open physis (growth plate) on radiographs and at least one year of growth remaining before age of skeletal maturity (typically ≤14 years in females, ≤16 years in males).

Disqualifiers

Sick Physis as in Blount's disease stages III-V or any partial or total physeal arrest caused by trauma, inflammation or neoplasia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tension Band Plate (TBP) Surgery

    Procedure/Surgery

    A guided growth procedure in which a non-locking 8-plate is placed extraperiosteally across the physis (growth plate) with two screws, one in the epiphysis and one in the metaphysis. This allows for gradual correction of coronal angular deformities without causing permanent growth arrest.

  • Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) Surgery

    Procedure/Surgery

    A minimally invasive procedure in which a partially threaded cannulated screw is inserted across the growth plate (transphyseal) to slow growth on one side of the bone. This technique allows for gradual correction of genu valgum and genu varum.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tension Band Plate (TBP) GroupActive comparator 1 intervention
Group B: Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Bone-Length Adjusted Angular Correction Rate (BLAACR)

The Bone-Length Adjusted Angular Correction Rate (BLAACR) measures the effectiveness of guided growth correction by normalizing the angular correction rate based on limb growth. This method reduces bias in comparing the Tension Band Plate (TBP) and Percutaneous Epiphysiodesis by Transphyseal Screw (PETS) by accounting for variations in growth rate among participants. The formula is: BLAACR = (Change in Angular Deformity) / (Increase in Bone Length), where: -- Change in Angular Deformity = Initial Angle - Final Angle * Increase in Bone Length = Initial Bone Length - Final Bone Length

Time frame
Measured at 3-month intervals until clinical correction is achieved, up to 12 months

Secondary outcomes

1

Angular Correction Rate (Degrees/Month)

Measures the rate of angular deformity correction over time without adjusting for bone growth. This is calculated as: (Initial Angle - Final Angle) / Total Months of Follow-up.

Time frame
Measured at 3-month intervals until clinical correction is achieved, up to 12 months
2

Complications (Pain, Infection, Hardware Migration/Breakage)

Assess the frequency and severity of complications related to TBP and PETS, including post-operative pain (measured using a visual analog scale), surgical site infections, implant migration, and hardware failure.

Time frame
Evaluated at each follow-up visit (3, 6, 9, 12 months)

Other outcomes

Sponsors and contacts

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