- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05717829
Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH) (DDH)
February 5, 2023 updated by: Hesham Mohamed Elbaseet, Assiut University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This Modified incision to make re -suturing of the capsule easier with multiple stitches.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hesaham M Elbaseet, MD
- Phone Number: +2001007780689
- Email: drhesham20@aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- faculty of medicine Assiut university
-
Contact:
- Hesham M Elbaseet, MD
- Phone Number: +2001007780689
- Email: drhesham20@aun.edu.eg
-
Sub-Investigator:
- Mohamed A Abdel zaher, Msc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 7 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 1-7 years old
- Primary DDH
Exclusion Criteria:
- Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
- Recurrent cases of DDH
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: modified hip capsular incision
make re -suturing of the capsule easier with multiple stitches.
|
modified incision to make re -suturing of the capsule easier with multiple stitches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of hip capsulorrhaphy
Time Frame: intraoperative
|
as regards operative time to do capsullorrhapy in minutes
|
intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Any complications detected
Time Frame: 1 year
|
as: infection -Recurrent dislocation -AVN
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hesaham Elbaseet, MD, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Qadir 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.
- Glorion 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.
- Clinical 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 3, 2023
Primary Completion (ANTICIPATED)
January 3, 2024
Study Completion (ANTICIPATED)
January 3, 2025
Study Registration Dates
First Submitted
January 14, 2023
First Submitted That Met QC Criteria
February 5, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 5, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCIDDH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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