Comparison Between Two Techniques of Capsulotomy During Capsulorrhaphy in Cases of Developmental Dysplasia of the Hip

U-shaped vs T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, Randomized Controlled Trial

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Procedure: U shaped capsular incision during capsulorrhaphy; Procedure: T-shaped capsular incision diuring capsulorraphy

Detailed Description

Developmental dysplasia of the hip: Developmental dysplasia of the hip is a spectrum of abnormalities of the developing hip joint that ranges from shallowness of the acetabulum to capsular laxity and instability to frank dislocation . Developmental dysplasia of the hip is relatively common, occurring in 1 of 1000 live births.

When surgical intervention is decided, open reduction is needed to remove any obstacle that hinders hip reduction. Capsulorrhaphy is an essential step for minimizing instability of the hip after reduction The classic T-shaped capsular incision is done by two incisions: Vertical limb parallel to femoral neck axis and a transverse one parallel to the inguinal ligament resulting into two layers . Suturing them back is somewhat cumbersome after femoral head reduction. Therefore, the suggested technique utilizes a U-shaped incision to make re-suturing of the capsule easier with multiple stitches, and this study compares the outcome between using T-shaped incision and U-shaped incision for capsulorrhaphy after open reduction Femoral osteotomy or Pelvic osteotomy can be used in certain circumstances.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71111
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: U-shaped group; Participants on which U shaped capsular incision will be used during capsulorrhaphy	Procedure: U shaped capsular incision during capsulorrhaphy; 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; Other Names: U-shaped Capsulotomy
Active Comparator: T-shaped group; Participants on which T shaped incision will be used during capsulorrhaphy	Procedure: T-shaped capsular incision diuring capsulorraphy; 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.; Other Names: T-shaped Capsulotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of stitches taken during capsulorrhaphy		1 year
Operative time of capsulorrhaphy	calculate the time needed to close the capsule of the hip	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
any complication detected	Sublaxation; Recurrent dislocation; proximal femoral growth disturbance; Supracondylar femoral fracture; Infection	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Smith's anesthesia for infants and children
• 6-Articular mobility in an African population.
• 7-persistent joint laxity and congenital dislocation of the hip

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Joint Dislocations; Hip Dislocation; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Developmental Dysplasia of the Hip
• Other Study ID Numbers: Capsulorrhaphy in DDH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No