NCT06439147

Brief Summary

comparison of the outcome between using U-shaped incision and T-shaped incision for capsulorrhaphy in management of Developmental dysplasia of the hip

Trial Health

55
Monitor

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 Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

October 11, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

May 23, 2024

Last Update Submit

January 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Modified Mackay's criteria as a clinical evaluation method

    Postoperative clinical evaluation Grade 1(Excellent):Painless,stable hip,no limp,more than 15 degrees of internal rotation Grade 2(Good):Painless,stable hip,slight limp or decreased motion;negative trendelenburg's sign Grade 3(Fair):Minimum pain,moderate stiffness;Positive trendelenburg sign Grade 4(Poor):Significant pain

    1 year

Secondary Outcomes (3)

  • Operative time ofcapsulorrhaphy

    1 year

  • Number of stitches taken during capsulorrhaphy

    1 year

  • any complication detected

    1 year

Study Arms (2)

U-shaped group

ACTIVE COMPARATOR

Participants on which U shaped capsular incision will be used during capsulorrhaphy

Procedure: U shaped capsular incision during capsulorrhaphy

T-shaped group

ACTIVE COMPARATOR

Participants on which T shaped incision will be used during capsulorrhaphy

Procedure: T-shaped capsular incision diuring capsulorraphy

Interventions

Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip,Incision is done with its base proximally. The transverse limb is 1 cm proximal to femoral neck base

Also known as: U-shaped Capsulotomy
U-shaped group

Incision of the capsule of the hip during open reduction of Developmental Dysplasia of the Hip done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two flabs.

Also known as: T-shaped Capsulotomy
T-shaped group

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients older than 1 year and younger than 4 years
  • Unilateral or bilateral cases

You may not qualify if:

  • Patients younger than 1 year and older than 4 years old
  • Secondary hip dislocation ,neuromuscular disorders (as cerebral palsy, myelodysplasia or arthrogryposis).
  • Patients who will undergo femoral shortening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71111, Egypt

Location

Related Publications (5)

  • McKay DW. A comparison of the innominate and the pericapsular osteotomy in the treatment of congenital dislocation of the hip. Clin Orthop Relat Res. 1974 Jan-Feb;(98):124-32. doi: 10.1097/00003086-197401000-00013. No abstract available.

    PMID: 4817221BACKGROUND
  • 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
  • Elbaseet HM, Abdelzaher MA. U-shaped hip capsular incision: An easier way to do hip capsulorrhaphy in developmental dysplasia of the hip - Technical note. Orthop Traumatol Surg Res. 2024 Jun;110(4):103625. doi: 10.1016/j.otsr.2023.103625. Epub 2023 Apr 21.

    PMID: 37086945BACKGROUND
  • Zargarbashi R, Bozorgmanesh M, Panjavi B, Vosoughi F. The path to minimizing instability in developmental dysplasia of the hip: is Capsulorrhaphy a necessity or a futile habit? BMC Musculoskelet Disord. 2021 Feb 17;22(1):199. doi: 10.1186/s12891-021-04065-3.

    PMID: 33596895BACKGROUND
  • Li Y, Hu W, Xun F, Lin X, Li J, Yuan Z, Liu Y, Canavese F, Xu H. Risk factors associated with unsatisfactory hip function in children with late-diagnosed developmental dislocation of the hip treated by open reduction. Orthop Traumatol Surg Res. 2020 Nov;106(7):1373-1381. doi: 10.1016/j.otsr.2020.03.018. Epub 2020 Jun 19.

    PMID: 32571742BACKGROUND

Related Links

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgery resident

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 3, 2024

Study Start

October 11, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations