Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
To determine the role of arthroscopy in treatment of the DDH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2025
CompletedMay 10, 2024
May 1, 2024
1.4 years
April 15, 2024
May 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Assessment of the cosmetic appearance .
3 month follow up
Assessment of the shortening
1 year follow up
Assessment the incidence stiffness and decrease range of motion of the affected hip
1 year follow up
Assessment the incidence of avascular necrosis in the affected hip
1 year follow up
Study Arms (2)
1 .Arthroscopically assisted
ACTIVE COMPARATORArthroscopically assisted in surgical reduction of the hip in patients with irreducible DDH before the walking age arm 1
2.open surgical reduction arm 2
ACTIVE COMPARATORopen surgical reduction of the hip in patients with irreducible DDH before the walking age arm 2
Interventions
Arthroscopically-Assisted reduction through anterolateral portal for visualization and other accessory portals for instrumentation to achieve reduction and postoperative immobilization in a hip spica.
Open reduction through a bikini incision anterior approach and postoperative immobilization in a hip spica.
Eligibility Criteria
You may qualify if:
- Age: - from nine months to 18 months.
- Irreducible Hip Dislocation.
You may not qualify if:
- Patient age: below 9 months or above 18 months.
- Teratologic hip dislocation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 24168117BACKGROUNDJenner 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.
PMID: 38396003BACKGROUNDDuman 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.
PMID: 30938234BACKGROUNDPresch 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.
PMID: 31489043BACKGROUNDBulut 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.
PMID: 15891724BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
April 15, 2024
First Posted
May 10, 2024
Study Start
May 15, 2024
Primary Completion
October 15, 2025
Study Completion
December 15, 2025
Last Updated
May 10, 2024
Record last verified: 2024-05