Developmental Dysplasia of the HipNCT06520436
Arthroscopic-Assisted Reduction of Hip Dislocation Via Sub-Adductor and Anterolateral Portals
A study testing Arthroscopic-Assisted Reduction in people with Developmental Dysplasia of the Hip, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Arthroscopic-Assisted Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with DDH in this study
Who cannot join
- Previous surgical treatment and those with teratologic or neuromuscular dislocations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic-Assisted Reduction for Developmental Dislocation of The Hip Through the Sub-Adductor and Anterolateral Portals
This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques.
Read the detailed description
Developmental dysplasia of the hip (DDH) encompasses a spectrum of pathological conditions including dislocation, subluxation, and deformities of the femoral head and acetabulum. The optimal surgical approach for DDH remains a subject of debate. The goal of successful treatment is achieving a stable concentric reduction and preventing future subluxation or dislocation.The aim of this study is to introduce the reliability of our arthroscopic-assisted surgical technique as a successful treatment for DDH that can achieve reduction with avoidance of sequelae which may be experienced following open reduction techniques.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Arthroscopic-Assisted Reduction
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic-Assisted ReductionProcedure or surgery
The arthroscopic-assisted reduction was used as a one-stage operative treatment for all hips. In addition to that, Dega pelvic osteotomy and/or femoral shortening and varus derotation osteotomies were performed when necessary.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic-Assisted Reduction | Experimental | Not described Receives: Procedure: Arthroscopic-Assisted Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular index
Measured: 1 year
Severin radiographic grading
Measured: 1 year
Modified Severin clinical grading
Measured: 1 year
Postoperative complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jan 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed El-Desouky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520436
- Sponsor's protocol ID
- MD-411-2018
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rashwan AS, El-Desouky M, Elbarbary H, Madbouly MAE, Khedr A. Arthroscopic-assisted reduction for Developmental Hip Dysplasia (DDH) through the sub-adductor and anterolateral portals; A 24-month follow-up prospective descriptive study. BMC Musculoskelet Disord. 2025 Jan 8;26(1):27. doi: 10.1186/s12891-024-08234-y.
PubMed 39773255
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic-Assisted Reduction for Developmental Dislocation of The Hip Through the Sub-Adductor and Anterolateral Portals
- ClinicalTrials.gov ID
- NCT06520436
- Acronym / sponsor ID
- MD-411-2018
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques.
Detailed description
Developmental dysplasia of the hip (DDH) encompasses a spectrum of pathological conditions including dislocation, subluxation, and deformities of the femoral head and acetabulum. The optimal surgical approach for DDH remains a subject of debate. The goal of successful treatment is achieving a stable concentric reduction and preventing future subluxation or dislocation.The aim of this study is to introduce the reliability of our arthroscopic-assisted surgical technique as a successful treatment for DDH that can achieve reduction with avoidance of sequelae which may be experienced following open reduction techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic-Assisted Reduction | Experimental | Procedure: Arthroscopic-Assisted Reduction |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with DDH in this study
Key exclusion criteria (1 listed)
- Previous surgical treatment and those with teratologic or neuromuscular dislocations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic-Assisted ReductionThe arthroscopic-assisted reduction was used as a one-stage operative treatment for all hips. In addition to that, Dega pelvic osteotomy and/or femoral shortening and varus derotation osteotomies were performed when necessary. | Procedure or surgery | Arthroscopic-Assisted Reduction |
Primary outcome
Acetabular index
Time frame: 1 year
Severin radiographic grading
Time frame: 1 year
Modified Severin clinical grading
Time frame: 1 year
Postoperative complications
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Derived from this study: PubMed 39773255Rashwan AS, El-Desouky M, Elbarbary H, Madbouly MAE, Khedr A. Arthroscopic-assisted reduction for Developmental Hip Dysplasia (DDH) through the sub-adductor and anterolateral portals; A 24-month follow-up prospective descriptive study. BMC Musculoskelet Disord. 2025 Jan 8;26(1):27. doi: 10.1186/s12891-024-08234-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic-Assisted Reduction in people with Developmental Dysplasia of the Hip, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetabular index (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06520436, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.