NCT06142305

Brief Summary

incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

6.8 years

First QC Date

November 16, 2023

Last Update Submit

November 25, 2023

Conditions

DDH

Keywords

DDHinsufficiency fractures

Outcome Measures

Primary Outcomes (1)

  • Number of patients with supracondylar femoral fracture

    Number of patients with supracondylar femoral fracture

    6 months

Study Arms (1)

DDH surgery

EXPERIMENTAL

DDH surgery open reduction and casting

Procedure: DDH surgery and casting

Interventions

DDH surgery and castingPROCEDURE

DDH surgery and casting

DDH surgery

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-7 years old
  • Primary DDH

You may not qualify if:

  • Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
  • Recurrent cases of DDH
  • Past history of ipsilateral distal femoral fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Clinical practice guideline: early detection of developmental dysplasia of the hip. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. American Academy of Pediatrics. Pediatrics. 2000 Apr;105(4 Pt 1):896-905. doi: 10.1542/peds.105.4.896.

    PMID: 10742345BACKGROUND

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 21, 2023

Study Start

January 1, 2017

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

not planning to share individual participant data (IPD)