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Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH) (DDH)

Primary Purpose

Developmental Hip Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified hip capsular incision
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Hip Dysplasia focused on measuring DDH, Developmental hip dysplasia, Capsulorrhaphy

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • faculty of medicine Assiut universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified hip capsular incision

Arm Description

make re -suturing of the capsule easier with multiple stitches.

Outcomes

Primary Outcome Measures

Feasibility of hip capsulorrhaphy
as regards operative time to do capsullorrhapy in minutes

Secondary Outcome Measures

Any complications detected
as: infection -Recurrent dislocation -AVN

Full Information

First Posted
January 14, 2023
Last Updated
February 5, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05717829
Brief Title
Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)
Acronym
DDH
Official Title
Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Hip Dysplasia
Keywords
DDH, Developmental hip dysplasia, Capsulorrhaphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective case series study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
modified hip capsular incision
Arm Type
Experimental
Arm Description
make re -suturing of the capsule easier with multiple stitches.
Intervention Type
Procedure
Intervention Name(s)
Modified hip capsular incision
Intervention Description
modified incision to make re -suturing of the capsule easier with multiple stitches.
Primary Outcome Measure Information:
Title
Feasibility of hip capsulorrhaphy
Description
as regards operative time to do capsullorrhapy in minutes
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Any complications detected
Description
as: infection -Recurrent dislocation -AVN
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hesaham M Elbaseet, MD
Phone
+2001007780689
Email
drhesham20@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesaham Elbaseet, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hesham M Elbaseet, MD
Phone
+2001007780689
Email
drhesham20@aun.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed A Abdel zaher, Msc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29951123
Citation
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.
Results Reference
background
PubMed Identifier
30534545
Citation
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.
Results Reference
background
PubMed Identifier
29203431
Citation
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.
Results Reference
background
PubMed Identifier
10742345
Citation
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.
Results Reference
result

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Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)

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