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

NCT ID: NCT06439147

Last Updated: 2025-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-11

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Developmental Dysplasia of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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U-shaped group

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

Group Type ACTIVE_COMPARATOR

U shaped capsular incision during capsulorrhaphy

Intervention Type PROCEDURE

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 group

Participants on which T shaped incision will be used during capsulorrhaphy

Group Type ACTIVE_COMPARATOR

T-shaped capsular incision diuring capsulorraphy

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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U-shaped Capsulotomy T-shaped Capsulotomy

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mostafa Thabet Hussien

Orthopedic surgery resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut university hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 4817221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29203431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37086945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33596895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32571742 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1006136/

6-Articular mobility in an African population.

https://boneandjoint.org.uk/article/10.1302/0301-620x.46b1.40

7-persistent joint laxity and congenital dislocation of the hip

Other Identifiers

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Capsulorrhaphy in DDH

Identifier Type: -

Identifier Source: org_study_id

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