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Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis

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ClinicalTrials.gov Identifier: NCT03689959
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Yahya Abdel Azeem Hassanein, Assiut University

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Degree of flexion deformity [ Time Frame: One year ]
The angle between the anterior borders of thigh and leg measured clinically with a goniometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Complications [ Time Frame: One year ]
    Wound complications, metal failure
  • Rate of correction [ Time Frame: One year ]
    Time needed for correction of deformity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Official Title  ICMJE Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Brief Summary The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.
Detailed Description

Flexion contractures of the knee are quite disabling. They produce deleterious effects on knee biomechanics, quadriceps function, energy expenditure during gait and the overall ability to ambulate. These deformities occur secondary to a number of different etiologies including; congenital, traumatic, inflammatory and neuromuscular disorders with cerebral palsy (CP) being on the top of the list.

The main aim of correction of sagittal plane deformities of the knee is to restore the range of motion. Surgical options available for correction of knee flexion contractures include soft tissue modification, acute correction by osteotomies, gradual correction by external fixators and growth modulation by hemiephysiodesis.Extensive soft tissue surgery may be needed for correction of knee deformities with potential risk of neurovascular damage and wound complications. Supracondylar extension osteotomies have been widely used, however prolonged immobilization and associated neurovascular insults have always been major concerns. External fixators are cumbersome and may produce muscle tethering and pin tract infections.

There are few studies in the literature reporting the use of anterior hemiepiphysiodesis for correction of knee flexion contracture.

Our study question can be summarized as follows; Is hemiepiphysiodesis by eight plates effective for correction of fixed knee flexion deformities in children ?

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Deformity
Intervention  ICMJE Procedure: Eight plate hemiepiphysiodesis
Patient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated.
Other Name: Guided growth
Study Arms  ICMJE Experimental: Patients
13 child with fixed knee flexion deformity more than 10° on one or both sides with 12 months or more predicted growth remaining subjected to eight plate hemiepiphysiodesis of the distal femur
Intervention: Procedure: Eight plate hemiepiphysiodesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fixed knee flexion deformity more than 10°
  • Unilateral or bilateral cases
  • 12 months or more predicted growth remaining
  • No response to non-operative treatment (physical therapy, bracing, casting);
  • Recurrent cases

Exclusion Criteria:

  • Dynamic deformities due to spasticity
  • Deformities responding to conservative treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed Y. Hassanein, M.Sc. +201008084749 mohamedyahya@aun.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689959
Other Study ID Numbers  ICMJE UMIN000018950
Has Data Monitoring Committee No
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  ICMJE Not Provided
Responsible Party Mohamed Yahya Abdel Azeem Hassanein, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Y. Hassanein, M.Sc. Assiut University
PRS Account Assiut University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP