NCT05081453

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jun 2023Dec 2028

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2026

Expected
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2028

Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

September 15, 2021

Last Update Submit

March 8, 2024

Conditions

TROCLEAR DYSPLASIA

Outcome Measures

Primary Outcomes (1)

  • measurement of the angle of the trochlear groove

    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.

    20 minutes

Secondary Outcomes (1)

  • patellar height

    15 minutes

Study Arms (2)

Pavlik harness treatment group

EXPERIMENTAL

Application of a pavlik harness for 2 months in position seeking 90º of flexion of both knees and 45º of hip flexion with some abduction. An ultrasound control is performed at 2 and 6 months

Device: pavlik harness

Control group without intervention

NO INTERVENTION

Control group without intervention. An ultrasound control is performed at 2 and 6 months

Interventions

pavlik harnessDEVICE

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

Pavlik harness treatment group

Eligibility Criteria

Age0 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term and preterm newborns \> 35 weeks
  • Breech presentation at birth.

You may not qualify if:

  • Infant cerebral palsy,
  • Developmental disorders
  • Chromosomal diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Related Publications (4)

  • Gray CJ, Shanahan MM. Breech Presentation. 2022 Nov 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448063/

    PMID: 28846227RESULT

  • Oye CR, Foss OA, Holen KJ. Breech presentation is a risk factor for dysplasia of the femoral trochlea. Acta Orthop. 2016 Feb;87(1):17-21. doi: 10.3109/17453674.2015.1089023. Epub 2015 Sep 18.

    PMID: 26381593RESULT

  • Oye CR, Foss OA, Holen KJ. Minor change in the sulcus angle during the first six years of life: a prospective study of the femoral trochlea development in dysplastic and normal knees. J Child Orthop. 2018 Jun 1;12(3):245-250. doi: 10.1302/1863-2548.12.180026.

    PMID: 29951124RESULT

  • Onor GI Jr, Yalcin S, Kaar SG, Pace JL, Ferrua P, Farrow LD. The Evaluation of Trochlear Osseous Morphology: An Epidemiologic Study. Orthop J Sports Med. 2021 Apr 2;9(4):2325967121994548. doi: 10.1177/2325967121994548. eCollection 2021 Apr.

    PMID: 33869646RESULT

Central Study Contacts

Joaquín JM Moya-Angeler Pérez-Mateos, Orthopedic surgeon

CONTACT

669412133jmoyaangeler@gmail.com

Domingo DM Maestre Cano, Doctor

CONTACT

616623746domingomsc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel controlled triple-blind randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 18, 2021

Study Start

June 1, 2023

Primary Completion (Estimated)

September 24, 2026

Study Completion (Estimated)

December 15, 2028

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

ES(1)