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Slipped Capital Femoral Epiphysis Treatment

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ClinicalTrials.gov Identifier: NCT03229590
Recruitment Status : Unknown
Verified July 2017 by Mohamed Ibrahim, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Ibrahim, Assiut University

Tracking Information
First Submitted Date July 19, 2017
First Posted Date July 25, 2017
Last Update Posted Date July 25, 2017
Estimated Study Start Date August 2017
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2017)
Harris Hip Score [ Time Frame: 6 months ]
this is a score for post operative evaluation of the hip (it is evaluate pain, support, Distance walked, Limp, Activities - shoes, socks, Stairs, Public transportation, Sitting, Range of motion) every item take a number then the summation of all numbers which ranged from 0 to 100 : <70 Poor 70 - 79 Fair 80-89 Good 90 -100 Excellent
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Slipped Capital Femoral Epiphysis Treatment
Official Title Safe Surgical Dislocation in Slipped Capital Femoral Epiphysis
Brief Summary Slipped capital femoral epiphysis represents approximately 10.8 cases per 100,000 children. The primary source for the blood supply of the head of the femur is the deep branch of the medial femoral circumflex artery. Loder described a classification for Slipped capital femoral epiphysis based on ability of the child to walk or not(walking=stable, non-walking=unstable).
Detailed Description

In slipped capital femoral epiphyses (SCFE), the severity of slippage correlates with poor long-term clinical outcome scores and radiographic evidence of osteoarthritis . In situ fixation of higher-grade SCFE has a low surgical risk and has been advocated by authors who believe the deformed hip has the potential to remodel with some restoration of the disturbed anatomic axes ; however, the remodeling potential remains controversial . Despite remodeling, the head-neck offset will remain abnormal . This is the cause of potential impingement of the femoral neck with the acetabular cartilage . Impingement in SCFE has been associated with damage of the acetabular cartilage, which may explain the early onset of osteoarthritis after SCFE .

Ganz et al. described a technique of surgical dislocation of hip involving trochanteric flip osteotomy and anterior capsulotomy preserving the blood supply to femoral head. The technique is based on extensive study of blood supply to the proximal femur. This technique allows us to completely dislocate the joint which allows complete access to intra articular pathology and allow reduction of the slipped capital femoral epiphysis .

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The purpose of this study is to evaluate management Of moderate and severe degrees Slipped capital femoral epiphysis cases by using surgical dislocation technique .
Condition SCFE
Intervention Procedure: Surgical dislocation
Reduction of slipped epiphysis by surgical dislocation
Study Groups/Cohorts Surgical dislocation
Reduction of slipped epiphysis via surgical dislocation technique
Intervention: Procedure: Surgical dislocation
Publications * Song MH, Jang WY, Park MS, Yoo WJ, Choi IH, Cho TJ. Slipped capital femoral epiphysis in children younger than 10 years old: clinical characteristics and efficacy of physeal-sparing procedures. J Pediatr Orthop B. 2018 Sep;27(5):379-386. doi: 10.1097/BPB.0000000000000485.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 22, 2017)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2020
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1- Patients with moderate Slipped capital femoral epiphysis 2- Patients with severe Slipped capital femoral epiphysis

Exclusion Criteria:

  • Patients with mild Slipped capital femoral epiphysis
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03229590
Other Study ID Numbers SCFE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Mohamed Ibrahim, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date July 2017