NCT05432505

Brief Summary

The treatment of developmental dysplasia of the hip (DDH) remains challenging, yet recent advances have refined our understanding of how best to survey for the condition during infancy, minimize complications during early treatment, and refine the selection of patients who can best benefit from hip preservation surgery. The ideal continued target would be to prevent missed hip dislocations or dysplasia during the infant period, prevent avascular necrosis (AVN) during early treatment, and decrease the incidence of total hip arthroplasty in adulthood related to undertreated DDH, The goal of the treatment is to achieve a concentric reduction of the femoral head into the acetabulum.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 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

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

July 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 21, 2022

Last Update Submit

June 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • modified HHS

    score for function of the hip

    6 months

Interventions

Identification of ligamentum teres ligamentum teres tenodesis

Eligibility Criteria

Age9 Months - 60 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The patients will be examined for: 1. Length of both lower limbs in relation to each other. 2. Length of both lower limbs according to patient age. 3. Presence of hump related to the outer surface of the hip 4. 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. Identification of ligamentum teres 2. ligamentum teres tenodesis

You may qualify if:

  • Patient with Developmental dysplasia of the hip (DDH) with :
  • Age: from 9 months -5 years old.
  • Virgin DDH.
  • Failed closed reduction in the management of DDH.
  • Failed open reduction through medial approach in the management of DDH

You may not qualify if:

  • Paralytic hip dislocation .
  • Post septic hip dislocation.
  • Traumatic hip dislocation .
  • Age : below 9 months or above 5 years.
  • 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

Study Design

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

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

July 21, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

June 27, 2022

Record last verified: 2022-06