NCT05717829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 14, 2023

Last Update Submit

February 5, 2023

Conditions

Keywords

DDHDevelopmental hip dysplasiaCapsulorrhaphy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of hip capsulorrhaphy

    as regards operative time to do capsullorrhapy in minutes

    intraoperative

Secondary Outcomes (1)

  • Any complications detected

    1 year

Study Arms (1)

modified hip capsular incision

EXPERIMENTAL

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

Procedure: Modified hip capsular incision

Interventions

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

modified hip capsular incision

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 1-7 years old
  • Primary DDH

You may not qualify if:

  • Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
  • Recurrent cases of DDH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Assiut university

Asyut, 71515, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 29951123BACKGROUND
  • 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.

    PMID: 30534545BACKGROUND
  • 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.

    PMID: 29203431BACKGROUND
  • 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.

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hesaham Elbaseet, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesaham M Elbaseet, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective case series study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 14, 2023

First Posted

February 8, 2023

Study Start

January 3, 2023

Primary Completion

January 3, 2024

Study Completion

January 3, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations