Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age

To determine the role of arthroscopy in treatment of the DDH.

Study Overview

• Status: Not yet recruiting
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Procedure: arthroscopically assisted; Procedure: open surgical reduction

Detailed Description

• The term developmental dysplasia of the hip (DDH) is composed of a spectrum of pathologies from stable acetabular dysplasia (femoral head centered in acetabulum but acetabulum is shallow) to concentric hips that are unstable (femoral head can be moved in and out of the confines of the acetabulum) and frankly dislocated hips in which there is a complete loss of contact between the femoral head and acetabulum.
• Open reduction , traditionally through a Smith - Peterson approach should be considered only if closed reduction cannot be performed.
• Medial open surgical reduction is a choice for the management of patients younger than 18 months with DDH. The minimal incision and minimal blood loss are advantages of this approach. Limited exposure of the hip joint is a disadvantage.
• The arthroscopic procedure was reported to represent a meaningful alternative to the open procedure due to a lower complication rate, a safe setting, a lower rate of residual dysplasia, no observed redislocation and low rate occurrence of osteonecrosis.
• All the intra-articular structures (hypertrophic ligamentum teres, transverse acetabular ligament, and pulvinar tissue) in the acetabulum that impede the reduction of the femoral head could be eliminated by using the arthroscopic technique.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed ebrahim, resident; Phone Number: 01050707974; Email: Mohamed.15259277@med.aun.edu.eg
• Study Contact Backup: Name: mohamed Abd El- Radi, dr; Phone Number: 01225338766; Email: mradi@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

• Inclusion Criteria:
• Age: - from nine months to 18 months.
• Irreducible Hip Dislocation.
• Exclusion Criteria:
• Patient age: below 9 months or above 18 months.
• Teratologic hip dislocation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 .Arthroscopically assisted; Arthroscopically assisted in surgical reduction of the hip in patients with irreducible DDH before the walking age arm 1	Procedure: arthroscopically assisted; Arthroscopically-Assisted reduction through anterolateral portal for visualization and other accessory portals for instrumentation to achieve reduction and postoperative immobilization in a hip spica.; Other Names: arthroscopically assisted surgical reduction
Active Comparator: 2.open surgical reduction arm 2; open surgical reduction of the hip in patients with irreducible DDH before the walking age arm 2	Procedure: open surgical reduction; Open reduction through a bikini incision anterior approach and postoperative immobilization in a hip spica.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination the success of reduction and incidence of redislocation rate	Documentation of concentric reduction of the hip in immediate postoperative MRI as an assessment tool for the success of the procedure.	immediately postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the cosmetic appearance .	Documentation the wound size after 3 months follow up in clinical examination as an assessment tool of cosmotic appearance	3 month follow up
Assessment of the shortening	Assessment the incidence of leg length discrepancy and shortening that affect walking after one year follow up in clinical examination and x-ray as an assessment tool of shortening	1 year follow up
Assessment the incidence stiffness and decrease range of motion of the affected hip	documentation the range of motion of the affected hip and incidence of stiffness after 6 months follow up in clinical examination as an assessment tool of stiffness.	1 year follow up
Assessment the incidence of avascular necrosis in the affected hip	documentation the incidence of avascular necrosis of the affected head of hip after one year follow up in clinical examination and x-ray	1 year follow up

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Nariman aboloyoun, Ass.Prof, Orthopedic and Trauma surgery at assiut university hospital; Study Director: Hatem Galal El-Din Zaki, prof, Orthopedic and Trauma surgery at assiut university hospital

Publications and helpful links

General Publications

• Roof AC, Jinguji TM, White KK. Musculoskeletal screening: developmental dysplasia of the hip. Pediatr Ann. 2013 Nov;42(11):229-35. doi: 10.3928/00904481-20131022-10.
• Jenner EA, Chauhan GS, Burahee A, Choudri J, Gardner A, Bache CE. Comparison of clinical and radiological outcomes for the anterior and medial approaches to open reduction in the treatment of bilateral developmental dysplasia of the hip: a systematic review protocol. Syst Rev. 2024 Feb 23;13(1):72. doi: 10.1186/s13643-023-02444-6.
• Duman S, Camurcu Y, Sofu H, Ucpunar H, Akbulut D, Yildirim T. Arthroscopic versus open, medial approach, surgical reduction for developmental dysplasia of the hip in patients under 18 months of age. Acta Orthop. 2019 Jun;90(3):292-296. doi: 10.1080/17453674.2019.1599775. Epub 2019 Apr 2.
• Presch C, Eberhardt O, Wirth T, Fernandez FF. Comparison of arthroscopic and open reduction of conservatively irreducible dislocated hips of children. J Child Orthop. 2019 Aug 1;13(4):377-384. doi: 10.1302/1863-2548.13.190057.
• Bulut O, Ozturk H, Tezeren G, Bulut S. Arthroscopic-assisted surgical treatment for developmental dislocation of the hip. Arthroscopy. 2005 May;21(5):574-9. doi: 10.1016/j.arthro.2005.01.004.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): October 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: hip arthroscopy in DDH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No