Developmental Dysplasia of the HipNCT06408987
Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age
A study testing arthroscopically assisted and open surgical reduction in people with Developmental Dysplasia of the Hip, run by Assiut University.
Trial summary
To determine the role of arthroscopy in treatment of the DDH. Read more about this study
- Who is it for?
- Ages 9 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- arthroscopically assisted and open surgical reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 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 9 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: - from nine months to 18 months.
- Irreducible Hip Dislocation.
Who cannot join
- Patient age: below 9 months or above 18 months.
- Teratologic hip dislocation
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- arthroscopically assisted, open surgical 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.
arthroscopically assistedProcedure or surgery
Also called arthroscopically assisted surgical reduction
Arthroscopically-Assisted reduction through anterolateral portal for visualization and other accessory portals for instrumentation to achieve reduction and postoperative immobilization in a hip spica.
open surgical reductionProcedure or surgery
Open reduction through a bikini incision anterior approach and postoperative immobilization in a hip spica.
| Study group | Role | What they receive |
|---|---|---|
| 1 .Arthroscopically assisted | Active comparator | Arthroscopically assisted in surgical reduction of the hip in patients with irreducible DDH before the walking age arm 1 Receives: 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 Receives: Procedure: open surgical reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately postoperative
Secondary outcomes (4)
Assessment of the cosmetic appearance .
Documentation the wound size after 3 months follow up in clinical examination as an assessment tool of cosmotic appearance
Measured: 3 month follow up
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
Measured: 1 year follow up
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.
Measured: 1 year follow up
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
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Assiut 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Ebrahim Abd Allah, Assiut University
- Investigators
- Nariman aboloyoun, Ass.Prof, Study director, Orthopedic and Trauma surgery at assiut university hospitalHatem Galal El-Din Zaki, prof, Study director, Orthopedic and Trauma surgery at assiut university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408987
- Sponsor's protocol ID
- hip arthroscopy in DDH
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 24168117Jenner 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 38396003Duman 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 30938234Presch 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 31489043Bulut 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopically Assisted Versus Open Surgical Reduction of the Hip in Patients With Irreducible DDH Before the Walking Age
- ClinicalTrials.gov ID
- NCT06408987
- Acronym / sponsor ID
- hip arthroscopy in DDH
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 10 May 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.
To determine the role of arthroscopy in treatment of the DDH.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 .Arthroscopically assisted | Active comparator | Procedure: arthroscopically assistedArthroscopically assisted in surgical reduction of the hip in patients with irreducible DDH before the walking age arm 1 |
| 2.open surgical reduction arm 2 | Active comparator | Procedure: open surgical reductionopen surgical reduction of the hip in patients with irreducible DDH before the walking age arm 2 |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: - from nine months to 18 months.
- Irreducible Hip Dislocation.
Key exclusion criteria (2 listed)
- Patient age: below 9 months or above 18 months.
- Teratologic 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 |
|---|---|---|
| arthroscopically assistedAlso: arthroscopically assisted surgical reductionArthroscopically-Assisted reduction through anterolateral portal for visualization and other accessory portals for instrumentation to achieve reduction and postoperative immobilization in a hip spica. | Procedure or surgery | 1 .Arthroscopically assisted |
| open surgical reductionOpen reduction through a bikini incision anterior approach and postoperative immobilization in a hip spica. | Procedure or surgery | 2.open surgical reduction arm 2 |
Primary outcome
Determination the success of reduction and incidence of redislocation rate
Time frame: immediately postoperative
Documentation of concentric reduction of the hip in immediate postoperative MRI as an assessment tool for the success of the procedure.
4 secondary outcomes
Assessment of the cosmetic appearance .
Time frame: 3 month follow up
Assessment of the shortening
Time frame: 1 year follow up
Assessment the incidence stiffness and decrease range of motion of the affected hip
Time frame: 1 year follow up
Assessment the incidence of avascular necrosis in the affected hip
Time frame: 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 24168117Roof 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.
- Background: PubMed 38396003Jenner 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.
- Background: PubMed 30938234Duman 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.
- Background: PubMed 31489043Presch 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.
- Background: PubMed 15891724Bulut 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.
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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.
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
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopically assisted and open surgical reduction in people with Developmental Dysplasia of the Hip, run by Assiut University.
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 2 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 mohamed ebrahim, resident (01050707974, Mohamed.15259277@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination the success of reduction and incidence of redislocation rate (time frame: immediately postoperative). 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 NCT06408987, which also lists 5 linked publications.
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 10 May 2024.