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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Brief Summary:
The study aims to assess the effectiveness of hemiephysiodesis using eight plates in correction of fixed knee flexion deformities in children.

Condition or disease Intervention/treatment Phase
Knee Deformity Procedure: Eight plate hemiepiphysiodesis Not Applicable

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 ?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correction of Fixed Knee Flexion Deformity in Children Using Eight-plate Hemiepiphysiodesis
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. Degree of flexion deformity [ Time Frame: One year ]
    The angle between the anterior borders of thigh and leg measured clinically with a goniometer


Secondary Outcome Measures :
  1. Complications [ Time Frame: One year ]
    Wound complications, metal failure

  2. Rate of correction [ Time Frame: One year ]
    Time needed for correction of deformity



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689959


Contacts
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Contact: Mohamed Y. Hassanein, M.Sc. +201008084749 mohamedyahya@aun.edu.eg

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71111
Contact: Mohamed Y. Hassanein, Msc.    +201008084749    mohamedyahya@aun.edu.eg   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Mohamed Y. Hassanein, M.Sc. Assiut University
Publications of Results:
Other Publications:
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Responsible Party: Mohamed Yahya Abdel Azeem Hassanein, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03689959    
Other Study ID Numbers: UMIN000018950
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Yahya Abdel Azeem Hassanein, Assiut University:
knee
flexion deformity
hemiepiphysiodesis
eight plate
children
Additional relevant MeSH terms:
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Congenital Abnormalities