Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children

NCT06747767 | Completed DMC

• 1 other identifier: 6
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

Arthroscopic-assisted reduction; Developmental dysplasia of the hip; Open surgical reduction; Pediatric orthopedic surgery; Avascular necrosis

Outcome Measures

Primary Outcomes (1)

• rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.

  2 years

Study Arms (2)

Arthroscopy

EXPERIMENTAL

Arthroscopic Reduction for Developmental Dysplasia of the Hip in Children

Procedure: Arthroscopy

Open Reduction

EXPERIMENTAL

Open Reduction for Developmental Dysplasia of the Hip in children

Procedure: Open reduction

Interventions

Arthroscopy PROCEDURE

Arthroscopy

Arthroscopy

Open reduction PROCEDURE

Open reduction

Open Reduction

Eligibility Criteria

• Age: 1 Year - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Erbil Teaching Hospital

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip; Osteonecrosis

Interventions

Arthroscopy; Open Fracture Reduction

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Fracture Fixation; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Faculty

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 15, 2022
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)