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
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2023
CompletedFirst Submitted
Initial submission to the registry
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJanuary 28, 2025
January 1, 2025
2.1 years
May 23, 2024
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 COMPARATORParticipants on which U shaped capsular incision will be used during capsulorrhaphy
T-shaped group
ACTIVE COMPARATORParticipants on which T shaped incision will be used during capsulorrhaphy
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
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.
Eligibility Criteria
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
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: 4817221BACKGROUNDGlorion 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: 29203431BACKGROUNDElbaseet 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: 37086945BACKGROUNDZargarbashi 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: 33596895BACKGROUNDLi 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
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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