NCT06442722

Brief Summary

The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 17, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

June 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 17, 2024

Last Update Submit

May 29, 2024

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (1)

  • Severin's grading

    radiological

    1 year

Study Arms (2)

DDH with capsulorrhaphy

ACTIVE COMPARATOR

one group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule

Procedure: DDH with capsulorrhaphy

DDH without capsulorrhaphy

ACTIVE COMPARATOR

group has no tightness of the hip capsule

Procedure: DDH without capsulorrhaphy

Interventions

DDH with capsulorrhaphyPROCEDURE

group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule ,

DDH with capsulorrhaphy
DDH without capsulorrhaphyPROCEDURE

group will not undergo capsulorrhaphy, a surgical procedure without tightness the hip capsule

DDH without capsulorrhaphy

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age: from 1 year to 6 years
  • sex: males and females
  • Children who received no operative treatment before.

You may not qualify if:

  • Children who were treated operatively before presentation.
  • Children who had teratologic, post septic or neuromuscular hip dislocation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty Medicin

Sohag, 82716, Egypt

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ali Bakheet, ass. lecturer

CONTACT

020-01010505552ali.mohamed@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 17, 2024

First Posted

June 4, 2024

Study Start

June 2, 2024

Primary Completion

June 2, 2025

Study Completion

December 1, 2025

Last Updated

June 4, 2024

Record last verified: 2024-05

Locations

EG(1)