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Not yet recruitingNCT06408987Updated May 10, 2024

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

An interventional study of arthroscopically assisted and open surgical reduction in Developmental Dysplasia of the Hip, sponsored by Assiut University. Not yet recruiting. Open to participants aged 9 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
9 Months to 18 Months
Sex
All
01

Study summary

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

Read the 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.
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Conditions studied

  • Developmental Dysplasia of the Hip
03

In context

Developmental Dysplasia of the Hip

114 studies on the registry are indexed under Developmental Dysplasia of the Hip; 17 are open to participants now.

This study's planned enrollment of 32 is below the median of 61 across 71 interventional studies indexed under Developmental Dysplasia of the Hip.

Browse Developmental Dysplasia of the Hip studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Procedurearthroscopically 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.

    Also known as: arthroscopically assisted surgical reduction

  • Procedureopen surgical reduction

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

06

What researchers measure

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.

    Time frame: immediately postoperative

Secondary outcomes

  1. Assessment of the cosmetic appearance .

    Documentation the wound size after 3 months follow up in clinical examination as an assessment tool of cosmotic appearance

    Time frame: 3 month follow up

  2. 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

    Time frame: 1 year follow up

  3. 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.

    Time frame: 1 year follow up

  4. 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

    Time frame: 1 year follow up

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 24168117 ↗
  • 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. PubMed 38396003 ↗
  • 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. PubMed 30938234 ↗
  • 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. PubMed 31489043 ↗
  • 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. PubMed 15891724 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06408987
Lead sponsor
Assiut University
Responsible party
Mohamed Mahmoud Ebrahim Abd Allah (doctor, Assiut University) — Principal investigator
First posted
May 10, 2024
Start date
May 15, 2024 (estimated)
Primary completion
Oct 15, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
May 10, 2024

Study contacts

mohamed ebrahim, resident
Contact
Mohamed.15259277@med.aun.edu.eg
01050707974
mohamed Abd El- Radi, dr
Contact
mradi@aun.edu.eg
01225338766
Nariman aboloyoun, Ass.Prof
study director · Orthopedic and Trauma surgery at assiut university hospital
Hatem Galal El-Din Zaki, prof
study director · Orthopedic and Trauma surgery at assiut university hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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