Clinical trial NCT06439147: Comparison Between Two Techniques of Capsulotomy During Capsulorrhaphy in Cases of Developmental Dysplasia of the Hip
Official title: U-shaped vs T-shaped Capsular Incision in Capsulorrhaphy During Surgery for Developmental Dysplasia of the Hip, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Mackay's criteria as a clinical evaluation method
timeFrame: 1 year
Secondary outcomes:
measure: Operative time ofcapsulorrhaphy
timeFrame: 1 year
measure: Number of stitches taken during capsulorrhaphy
timeFrame: 1 year
measure: any complication detected
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
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.
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.
citation: 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.
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.
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.