Surgical Treatment of DDH With and Without Capsulorrhaphy | NCT06442722

Studies
Surgical Treatment of DDH With and Without Capsulorrhaphy

NCT06442722

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jun 4, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Developmental Dysplasia of the Hip

Interventions

DDH with capsulorrhaphy
DDH without capsulorrhaphy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2024Estimated

Primary Completion Date

Jun 2, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

May 17, 2024

First Submission Date that Met QC Criteria

May 29, 2024

First Posted Date

Jun 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2024

Last Update Posted Date

Jun 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .:

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DDH with capsulorrhaphy	Procedure	group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule ,	DDH with capsulorrhaphy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severin's grading	radiological	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ali Bakheet, ass. lecturer	Contact	020-01010505552		ali.mohamed@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag Faculty Medicin		Sohag		82716	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000082602	Developmental Dysplasia of the Hip

Ancestor Terms

ID	Term
D006617	Hip Dislocation
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided