- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06747767
Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children
December 26, 2024 updated by: Abdulkadr Muhammed S. Alany, Hawler Medical University
Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children: A Randomized Controlled Trial
This study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children.
By comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (DDH) in young children using a comparative, parallel-group design.
The technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals.
By employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery.
The surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables.
Additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage.
The study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced.
In this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.
Study Type
Interventional
Enrollment (Actual)
43
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 Locations
-
-
-
Erbil, Iraq, 44001
- Erbil Teaching Hospital
-
-
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
No
Description
Inclusion Criteria:
- Children diagnosed with DDH (Tönnis grade II-IV)
- Age range: 12 to 24 months at the time of the first surgical reduction
- A documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment
Exclusion Criteria:
- Presence of neuromuscular disorders
- Teratologic hip dislocation
- Prior surgical intervention on the affected hip
- Incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arthroscopy
Arthroscopic Reduction for Developmental Dysplasia of the Hip in Children
|
Arthroscopy
|
|
Experimental: Open Reduction
Open Reduction for Developmental Dysplasia of the Hip in children
|
Open reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 15, 2022
Primary Completion (Actual)
December 10, 2024
Study Completion (Actual)
December 10, 2024
Study Registration Dates
First Submitted
December 18, 2024
First Submitted That Met QC Criteria
December 18, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 26, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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