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

NCT ID: NCT06747767

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2024-12-10

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.

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.

Conditions

Developmental Dysplasia of the Hip (DDH)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arthroscopy

Arthroscopic Reduction for Developmental Dysplasia of the Hip in Children

Group Type: EXPERIMENTAL

Arthroscopy

Intervention Type: PROCEDURE

Arthroscopy

Open Reduction

Open Reduction for Developmental Dysplasia of the Hip in children

Group Type: EXPERIMENTAL

Open reduction

Intervention Type: PROCEDURE

Open reduction

Interventions

Arthroscopy

Arthroscopy

Intervention Type: PROCEDURE

Open reduction

Open reduction

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Abdulkadr Muhammed S. Alany

University Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erbil Teaching Hospital

Erbil, , Iraq

Countries

Iraq

Other Identifiers

6

Identifier Type: -

Identifier Source: org_study_id