Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia

Condition(s) studied

Investigational drug(s) / intervention(s)

pavlik harness: The application of a pavlik harness will be carried out in the intervention group. It will follow a protocol similar to that of the treatment of hip dysplasia in terms of follow-up and safety

Study summary

Title

Early identification and treatment of developmental trochlear femoral dysplasia.

Objectives

To identify developmental trochlear femoral dysplasia (DTFD) in the newborn early after birth by ultrasound and evaluate the effect of its treatment with a modificed Pavlik harness.

Study design

Randomized triple-blind clinical trial.

Study population

Newborns with risk factors for the development of DTFD.

Treatment of subjects

Treatment using a modified Pavlik harness currently used for the treatment of developmental dysplasia of the hip (CDD) over a period of two months.

Variables analyzed

Trochlear groove angles measured by ultrasound before and after the intervention in the treatment group and control group.

Follow-up

Two weeks, eight weeks and six months.

Statistic analysis

Student's t test will be used for related samples to compare and analyze the results of each group at the beginning and after the treatment (intervention group) or follow-up (control group). Study will be triple blinded.

Eligibility

Primary outcome measure(s)

• measurement of the angle of the trochlear groove — 20 minutes
  It is performed with ultrasound on the subject's knee. It is carried out by orienting the axis of the leg with the transverse probe. The image is focused on the ossified nucleus of the distal femur and oriented so that both non-ossified femoral condyles are visible. The measurement of the angle of the trochlear groove is taken from the nadir of the trochlea along the lines of best fit of the medial and lateral walls of the trochlea.

Trial sites (1)