NCT05603858

Brief Summary

Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

October 29, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 29, 2022

Last Update Submit

October 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • modified Harris Hip Score

    score for function of the hip

    6 months

Study Arms (1)

Tenodesis by end button

open reduction of the dislocated hip and stabilization by end button

Procedure: Tenodesis by end button

Interventions

open reduction of the dislocated hip and stabilization by end button

Tenodesis by end button

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The patients will be examined for: Length of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views) An addition to the steps of the open reduction, the following were done: 1. Trans articular suturing 2. End button tenodesis

You may qualify if:

  • \- Patient with Developmental dysplasia of the hip (DDH) with :
  • Age: up to 9 years old.
  • Recurrent DDH .
  • Failed open reduction through medial approach in the management of DDH.
  • Traumatic hip dislocation .

You may not qualify if:

  • Paralytic hip dislocation .
  • Post septic hip dislocation.
  • Refusal to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.

    PMID: 32730146BACKGROUND
  • Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.

    PMID: 29716513BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

ahmed khashaba, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2022

First Posted

November 3, 2022

Study Start

November 29, 2022

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10