NCT06408987

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

April 15, 2024

Last Update Submit

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 COMPARATOR

Arthroscopically assisted in surgical reduction of the hip in patients with irreducible DDH before the walking age arm 1

Procedure: arthroscopically assisted

2.open surgical reduction arm 2

ACTIVE COMPARATOR

open surgical reduction of the hip in patients with irreducible DDH before the walking age arm 2

Procedure: open surgical reduction

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.

Also known as: arthroscopically assisted surgical reduction
1 .Arthroscopically assisted

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

2.open surgical reduction arm 2

Eligibility Criteria

Age9 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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: 24168117BACKGROUND
  • 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.

    PMID: 38396003BACKGROUND
  • 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.

    PMID: 30938234BACKGROUND
  • 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.

    PMID: 31489043BACKGROUND
  • 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.

    PMID: 15891724BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • 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

    STUDY DIRECTOR

Central Study Contacts

mohamed ebrahim, resident

CONTACT

mohamed Abd El- Radi, dr

CONTACT

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