Surgical Treatment of DDH With and Without Capsulorrhaphy

May 29, 2024 updated by: Ali Abdelaal Bakheet, Sohag University

Evaluation of Surgical Treatment Outcomes for Developmental Dysplasia of Hip With and Without Capsulorrhaphy : a Comparative Study

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 .:

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DDH with capsulorrhaphy
one group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule
Procedure: DDH with capsulorrhaphy
group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule ,
Active Comparator: DDH without capsulorrhaphy
group has no tightness of the hip capsule
Procedure: DDH without capsulorrhaphy
group will not undergo capsulorrhaphy, a surgical procedure without tightness the hip capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severin's grading
Time Frame: 1 year
radiological
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 2, 2024

Primary Completion (Estimated)

June 2, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-04-06MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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