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

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06439147
• Other study ID #: Capsulorrhaphy in DDH
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. 2023 Apr 21:103625. doi: 10.1016/j.otsr.2023.103625. Online ahead of print. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time ofcapsulorrhaphy	calculate the time needed to close the capsule of the hip	1 year
Secondary	Number of stitches taken during capsulorrhaphy		1 year
Secondary	any complication detected	Recurrent dislocation,pain,Avascular necrosis of the hip	1 year

External Links

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