Developmental Hip DysplasiaDDHNCT05717829
Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)
A study testing Modified hip capsular incision in people with Developmental Hip Dysplasia, run by Assiut University at 1 site in Egypt.
Trial summary
Developmental dysplasia of the hip (DDH) is the commonest hip problem seen by pediatric orthopaedic surgeons (1). DDH refers to an abnormal configuration of, or relationship between, the femoral head and the acetabulum .Principals of surgical treatment of DDH, however, always include reduction and stabilization. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Developmental Hip Dysplasia
- What is being tested?
- Modified hip capsular incision
- 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
- 3 Jan 2023to 3 Jan 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-7 years old
- Primary DDH
Who cannot join
- Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
- Recurrent cases of DDH
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Assiut university
Asyut, 71515
Hesham M Elbaseet, MD, +2001007780689, drhesham20@aun.edu.eg
Mohamed A Abdel zaher, Msc
About this study
Developmental dysplasia of the hip (DDH) is the commonest hip problem seen by pediatric orthopaedic surgeons (1). DDH refers to an abnormal configuration of, or relationship between, the femoral head and the acetabulum .Principals of surgical treatment of DDH, however, always include reduction and stabilization. These principals could be applied by conservative or surgical means (2). Goal of Treatment options to Obtain and maintain reduction without damaging femoral head. Surgical Stabilization might be required in cases with failed conservative treatment, residual dysplasia or older children with neglected DDH. Surgical stabilization is generally achieved by a reduction into a near anatomical position and a complementary capsulorrhaphy (3). In the classic T-shaped capsular incision, the vertical branch parallel to the axis of the neck and the horizontal branch 5 mm from the iliac insertion of the capsule, from anterior and downward to posterior and upward. Two flaps are thus obtained (4). It was noticed that doing capsulorrhaphy after head reduction is cumbersome with this technique because it needs shallow-curved needles while suturing in narrow field and sometimes the suture material gets avulsed from medial flab. A suggested technique by doing a modified incision to make re -suturing of the capsule easier with multiple stitches.
Read the detailed description
This Modified incision to make re -suturing of the capsule easier with multiple stitches.
- Conditions
- Developmental Hip Dysplasia
- Being tested
- Modified hip capsular incision
- Keywords
- DDH, Developmental hip dysplasia, 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.
Modified hip capsular incisionProcedure or surgery
modified incision to make re -suturing of the capsule easier with multiple stitches.
| Study group | Role | What they receive |
|---|---|---|
| modified hip capsular incision | Experimental | make re -suturing of the capsule easier with multiple stitches. Receives: Procedure: Modified hip capsular incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of hip capsulorrhaphy
as regards operative time to do capsullorrhapy in minutes
Measured: intraoperative
Secondary outcomes (1)
Any complications detected
as: infection -Recurrent dislocation -AVN
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 posted8 Feb 2023
- Study start3 Jan 2023
- Primary completion3 Jan 2024 (estimated)
- Study completion3 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Developmental Hip DysplasiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective case series study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Mohamed Elbaseet, Assiut University
- Investigators
- Hesaham Elbaseet, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717829
- Sponsor's protocol ID
- MCIDDH
- Acronym
- DDH
- Status last verified
- Feb 2023
- First submitted
- 14 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alves C, Truong WH, Thompson MV, Suryavanshi JR, Penny CL, Do HT, Dodwell ER. Diagnostic and treatment preferences for developmental dysplasia of the hip: a survey of EPOS and POSNA members. J Child Orthop. 2018 Jun 1;12(3):236-244. doi: 10.1302/1863-2548.12.180034.
PubMed 29951123Qadir I, Ahmad S, Zaman AU, Khan CM, Ahmad S, Aziz A. One-stage Hip Reconstruction for Developmental Hip Dysplasia in Children over 8 Years of Age. Hip Pelvis. 2018 Dec;30(4):260-268. doi: 10.5371/hp.2018.30.4.260. Epub 2018 Dec 6.
PubMed 30534545Glorion C. Surgical reduction of congenital hip dislocation. Orthop Traumatol Surg Res. 2018 Feb;104(1S):S147-S157. doi: 10.1016/j.otsr.2017.04.021. Epub 2017 Dec 2.
PubMed 29203431Clinical practice guideline: early detection of developmental dysplasia of the hip. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. American Academy of Pediatrics. Pediatrics. 2000 Apr;105(4 Pt 1):896-905. doi: 10.1542/peds.105.4.896.
PubMed 10742345
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)
- ClinicalTrials.gov ID
- NCT05717829
- Acronym / sponsor ID
- DDH / MCIDDH
- Conditions
- Developmental Hip Dysplasia
- Keywords
- DDH, Developmental hip dysplasia, Capsulorrhaphy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 3 Jan 2024 (estimated)
- Study completion
- 3 Jan 2025 (estimated)
- First posted
- 8 Feb 2023 (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.
Developmental dysplasia of the hip (DDH) is the commonest hip problem seen by pediatric orthopaedic surgeons (1). DDH refers to an abnormal configuration of, or relationship between, the femoral head and the acetabulum .Principals of surgical treatment of DDH, however, always include reduction and stabilization. These principals could be applied by conservative or surgical means (2). Goal of Treatment options to Obtain and maintain reduction without damaging femoral head. Surgical Stabilization might be required in cases with failed conservative treatment, residual dysplasia or older children with neglected DDH. Surgical stabilization is generally achieved by a reduction into a near anatomical position and a complementary capsulorrhaphy (3). In the classic T-shaped capsular incision, the vertical branch parallel to the axis of the neck and the horizontal branch 5 mm from the iliac insertion of the capsule, from anterior and downward to posterior and upward. Two flaps are thus obtained (4). It was noticed that doing capsulorrhaphy after head reduction is cumbersome with this technique because it needs shallow-curved needles while suturing in narrow field and sometimes the suture material gets avulsed from medial flab. A suggested technique by doing a modified incision to make re -suturing of the capsule easier with multiple stitches.
Detailed description
This Modified incision to make re -suturing of the capsule easier with multiple stitches.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective case series study
| Arm | Type | Receives |
|---|---|---|
| modified hip capsular incision | Experimental | Procedure: Modified hip capsular incisionmake re -suturing of the capsule easier with multiple stitches. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 1-7 years old
- Primary DDH
Key exclusion criteria (2 listed)
- Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
- Recurrent cases of DDH
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 |
|---|---|---|
| Modified hip capsular incisionmodified incision to make re -suturing of the capsule easier with multiple stitches. | Procedure or surgery | modified hip capsular incision |
Primary outcome
Feasibility of hip capsulorrhaphy
Time frame: intraoperative
as regards operative time to do capsullorrhapy in minutes
1 secondary outcome
Any complications detected
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 29951123Alves C, Truong WH, Thompson MV, Suryavanshi JR, Penny CL, Do HT, Dodwell ER. Diagnostic and treatment preferences for developmental dysplasia of the hip: a survey of EPOS and POSNA members. J Child Orthop. 2018 Jun 1;12(3):236-244. doi: 10.1302/1863-2548.12.180034.
- Background: PubMed 30534545Qadir I, Ahmad S, Zaman AU, Khan CM, Ahmad S, Aziz A. One-stage Hip Reconstruction for Developmental Hip Dysplasia in Children over 8 Years of Age. Hip Pelvis. 2018 Dec;30(4):260-268. doi: 10.5371/hp.2018.30.4.260. Epub 2018 Dec 6.
- Background: PubMed 29203431Glorion C. Surgical reduction of congenital hip dislocation. Orthop Traumatol Surg Res. 2018 Feb;104(1S):S147-S157. doi: 10.1016/j.otsr.2017.04.021. Epub 2017 Dec 2.
- Results publication: PubMed 10742345Clinical practice guideline: early detection of developmental dysplasia of the hip. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. American Academy of Pediatrics. Pediatrics. 2000 Apr;105(4 Pt 1):896-905. doi: 10.1542/peds.105.4.896.
- 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.
Hesaham Elbaseet, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified hip capsular incision in people with Developmental Hip Dysplasia, run by Assiut 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 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 8 Feb 2023. 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 Hesaham M Elbaseet, MD (+2001007780689, drhesham20@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of hip capsulorrhaphy (time frame: intraoperative). 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 NCT05717829, which also lists 4 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 8 Feb 2023.