Developmental Dysplasia of the Hip (DDH)NCT06747767
Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children
A study testing Arthroscopy and Open reduction in people with Developmental Dysplasia of the Hip (DDH), run by Hawler Medical University at 1 site in Iraq.
Trial summary
This study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Developmental Dysplasia of the Hip (DDH)
- What is being tested?
- Arthroscopy and Open reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2022to 10 Dec 2024
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with DDH (Tönnis grade II-IV)
- Age range: 12 to 24 months at the time of the first surgical reduction
- A documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment
Who cannot join
- Presence of neuromuscular disorders
- Teratologic hip dislocation
- Prior surgical intervention on the affected hip
- Incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children: A Randomized Controlled Trial
This study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. By comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.
Read the detailed description
This investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (DDH) in young children using a comparative, parallel-group design. The technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals. By employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery. The surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables. Additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage. The study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced. In this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Being tested
- Arthroscopy, Open reduction
- Keywords
- Arthroscopic-assisted reduction, Developmental dysplasia of the hip, Open surgical reduction, Pediatric orthopedic surgery, Avascular necrosis
- Medical subject headings
- Developmental Dysplasia of the Hip, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroscopyProcedure or surgery
Arthroscopy
Open reductionProcedure or surgery
Open reduction
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopy | Experimental | Arthroscopic Reduction for Developmental Dysplasia of the Hip in Children Receives: Procedure: Arthroscopy |
| Open Reduction | Experimental | Open Reduction for Developmental Dysplasia of the Hip in children Receives: Procedure: Open reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start15 Jan 2022
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
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 Hip (DDH)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkadr Muhammed S. Alany, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747767
- Sponsor's protocol ID
- 6
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of Arthroscopic Versus Open Reduction for Developmental Dysplasia of the Hip in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06747767
- Acronym / sponsor ID
- 6
- Conditions
- Developmental Dysplasia of the Hip (DDH)
- Keywords
- Arthroscopic-assisted reduction, Developmental dysplasia of the hip, Open surgical reduction, Pediatric orthopedic surgery, Avascular necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 24 Dec 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 was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. By comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.
Detailed description
This investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (DDH) in young children using a comparative, parallel-group design. The technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals. By employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery. The surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables. Additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage. The study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced. In this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopy | Experimental | Procedure: ArthroscopyArthroscopic Reduction for Developmental Dysplasia of the Hip in Children |
| Open Reduction | Experimental | Procedure: Open reductionOpen Reduction for Developmental Dysplasia of the Hip in children |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children diagnosed with DDH (Tönnis grade II-IV)
- Age range: 12 to 24 months at the time of the first surgical reduction
- A documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment
Key exclusion criteria (4 listed)
- Presence of neuromuscular disorders
- Teratologic hip dislocation
- Prior surgical intervention on the affected hip
- Incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)
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 |
|---|---|---|
| ArthroscopyArthroscopy | Procedure or surgery | Arthroscopy |
| Open reductionOpen reduction | Procedure or surgery | Open Reduction |
Primary outcome
rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively.
Time frame: 2 years
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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 Arthroscopy and Open reduction in people with Developmental Dysplasia of the Hip (DDH), run by Hawler Medical University at 1 site in Iraq.
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 4 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 27 Dec 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 Iraq. 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?
rate of hip redislocation documented clinically and radiographically at 6, 12, and 24 months postoperatively. (time frame: 2 years). 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 27 Dec 2024.