Developmental Dysplasia of the HipNCT06442722
Surgical Treatment of DDH With and Without Capsulorrhaphy
A study testing DDH with capsulorrhaphy and DDH without capsulorrhaphy in people with Developmental Dysplasia of the Hip, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- DDH with capsulorrhaphy and DDH without capsulorrhaphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2024to 1 Dec 2025
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age: from 1 year to 6 years
- sex: males and females
- Children who received no operative treatment before.
Who cannot join
- Children who were treated operatively before presentation.
- Children who had teratologic, post septic or neuromuscular hip dislocation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag Faculty Medicin
Sohag, 82716
Ali Bakheet, ass.lecturer, 020-01010505552, ali.mohamed@med.sohag.edu.eg
About this study
Official title: Evaluation of Surgical Treatment Outcomes for Developmental Dysplasia of Hip With and Without Capsulorrhaphy : a Comparative Study
The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- DDH with capsulorrhaphy, DDH without capsulorrhaphy
- 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.
DDH with capsulorrhaphyProcedure or surgery
group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule ,
DDH without capsulorrhaphyProcedure or surgery
group will not undergo capsulorrhaphy, a surgical procedure without tightness the hip capsule
| Study group | Role | What they receive |
|---|---|---|
| DDH with capsulorrhaphy | Active comparator | one group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule Receives: Procedure: DDH with capsulorrhaphy |
| DDH without capsulorrhaphy | Active comparator | group has no tightness of the hip capsule Receives: Procedure: DDH without capsulorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severin's grading
radiological
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 posted4 Jun 2024
- Study start2 Jun 2024 (estimated)
- Primary completion2 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Abdelaal Bakheet, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442722
- Sponsor's protocol ID
- Soh-Med-24-04-06MD
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Treatment Outcomes for Developmental Dysplasia of Hip With and Without Capsulorrhaphy : a Comparative Study
- ClinicalTrials.gov ID
- NCT06442722
- Acronym / sponsor ID
- Soh-Med-24-04-06MD
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Jun 2024 (estimated)
- Primary completion
- 2 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Jun 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.
The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDH with capsulorrhaphy | Active comparator | Procedure: DDH with capsulorrhaphyone group will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule |
| DDH without capsulorrhaphy | Active comparator | Procedure: DDH without capsulorrhaphygroup has no tightness of the hip capsule |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age: from 1 year to 6 years
- sex: males and females
- Children who received no operative treatment before.
Key exclusion criteria (2 listed)
- Children who were treated operatively before presentation.
- Children who had teratologic, post septic or neuromuscular hip dislocation.
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 |
|---|---|---|
| DDH with capsulorrhaphygroup will undergo capsulorrhaphy, a surgical procedure to tighten the hip capsule , | Procedure or surgery | DDH with capsulorrhaphy |
| DDH without capsulorrhaphygroup will not undergo capsulorrhaphy, a surgical procedure without tightness the hip capsule | Procedure or surgery | DDH without capsulorrhaphy |
Primary outcome
Severin's grading
Time frame: 1 year
radiological
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDH with capsulorrhaphy and DDH without capsulorrhaphy in people with Developmental Dysplasia of the Hip, run by Sohag 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Bakheet, ass. lecturer (020-01010505552, ali.mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severin's grading (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.