MedTrace Logo

Early Identification and Treatment of Developmental Trochlear Femoral Dysplasia

NCT05081453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-12

No results posted yet for this 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.

Conditions

  • TROCLEAR DYSPLASIA

Interventions

DEVICE

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

Sponsors & Collaborators

  • Joaquín Moya-Angeler Pérez-Mateos

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2026-09-24
Completion
2028-12-15

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05081453 on ClinicalTrials.gov