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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03689959
Collaborator
(none)
13
1
1
39
0.3

Study Details

Study Description

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
  • Procedure: Eight plate hemiepiphysiodesis
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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 Names:
  • Guided growth
  • Outcome Measures

    Primary Outcome Measures

    1. Degree of flexion deformity [One year]

      The angle between the anterior borders of thigh and leg measured clinically with a goniometer

    Secondary Outcome Measures

    1. Complications [One year]

      Wound complications, metal failure

    2. Rate of correction [One year]

      Time needed for correction of deformity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Hospital Assiut Egypt 71111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Mohamed Y. Hassanein, M.Sc., Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Yahya Abdel Azeem Hassanein, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03689959
    Other Study ID Numbers:
    • UMIN000018950
    First Posted:
    Oct 1, 2018
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    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, Principal Investigator, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2021