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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06408987
Other study ID # hip arthroscopy in DDH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date December 15, 2025

Study information

Verified date May 2024
Source Assiut University
Contact mohamed ebrahim, resident
Phone 01050707974
Email Mohamed.15259277@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date December 15, 2025
Est. primary completion date October 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 18 Months
Eligibility - 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 Design


Related Conditions & MeSH terms


Intervention

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.
open surgical reduction
Open reduction through a bikini incision anterior approach and postoperative immobilization in a hip spica.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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