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External Fixator Assisted Genu Varum Correction

Primary Purpose

Deformity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External fixator assisted plaing
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deformity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18years old or more
  2. Varus 20 degrees or more

Exclusion Criteria:

  1. Contraindication to internal fixation
  2. Associated osteoarthritis

Sites / Locations

    Outcomes

    Primary Outcome Measures

    assesment of accuracy of correction of high degree genu varum using this method of correction.
    assessment of mechanical axis deviation in degrees, mechanical tibiofemral angle in degrees, medial proximal tibial angle in degrees and the position of mechanical axis ratio. They are all measured in the immediate post operative long film and the long film after one year. The normal angles are known documented angles so, we will compare the preoperative and postoperative angles with the normal ones.Immediate postoperative long film on the lower limbs to compare pre and postoperative angles with the normal angles. Another long film is done after one year to follow up the achieved correction

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2017
    Last Updated
    April 28, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03443648
    Brief Title
    External Fixator Assisted Genu Varum Correction
    Official Title
    Fixator Assisted Plating for Correction of High Degree Genu Varum Deformity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    March 31, 2020 (Anticipated)
    Study Completion Date
    March 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Assessment of accuracy of correction of genu varum more than 20 degrees using external fixator assisted plating. Intraoperatively, the operative time needed for completion of accurate correction, torniquet use, blood loss will be assessed. Postoperative complications either early ones like infection, thromboembolic complications, peroneal nerve palsy or late post operative complications like implant failure, delayed union, non union and bone healing time will be assessed..
    Detailed Description
    Malalignment prevents proper transmission of forces across the knee leading to advance or even start the progression of osteoarthritis.Preoperative planning is necessary to identify the level and magnitude of the deformity. Corrections can be performed acutely or gradually. Acute correction can be achieved by opening wedge, closing wedge or dome osteotomies followed by internal fixation. On the other hand, gradual correction can be achieved by osteotomy with external fixation. Although osteotomy with internal fixation is more convenient to the patient than external fixator, it has many drawbacks. These include the need for large surgical exposure, soft tissue stripping and difficulty executing precise deformity correction. Meticulous preoperative planning is important when internal fixation is planed. It also needs to be executed precisely till fixation is completed. Under-correction or over-correction is possible while executing the procedure. Furthermore, iatrogenic deformity in other planes may also develop. If such a deformity is significant, it may adversely affect the function or may lead to excessive loading on adjacent joints. In some cases, revision of surgery for further correction may be required to correct this residual or iatrogenic deformity. External fixation can be used for gradual correction of genu varum. In spite of the disadvantages of external fixation like being uncomfortable for the patient, tethering soft tissue, associated pin site infection and irritation , it is re-adjustable postoperatively. This allows controlled accurate correction of the mechanical axis of the lower limb. Our study is implicated on correction of high degree genu varum which is more than 20 degrees .To correct such deformity, it is difficult to calculate the amount of wedge opening intraoperative. The described trigonometric calculation of the size of the base is described for deformity less than 20 degrees .In this study we are going to use a hybrid technique of both external and internal fixation, so we can make use of the benefits of both internal and external fixation techniques External fixation by limb reconstruction system (LRS) or Taylor Spatial frame(TSF) is used to control and stabilize fragments while performing the desired correction. A locked T plate is then applied to stabilize the fully corrected osteotomy. This allows intraoperative removal of the external fixator without loss of correction. Then we compare the planned correction with the achieved correction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deformity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    External fixator assisted plaing
    Intervention Description
    The plate length is marked on the skin. Limb reconstruction system (LRS) with one swivel clamp or Taylor Spatial frame (TSF) is used in all cases. The fixator is put in a plane parallel to that of the deformity. Two tapered pins are placed on either side of the planned osteotomy site and passed at a distance from the osteotomy so that they will not impede the subsequent internal fixation. Swivel clamps or the struts of the TSF are aligned in such a way that full correction is achieved. After osteotomy, swivel clamp is loosened and angular correction is achieved. Translation is carried out according to preoperative planning. If readjustment is required the swivel clamps or TSF struts are loosened and further correction is carried out. Once desired correction is achieved, the clamps or struts are tightened. Definitive internal fixation is carried out while external fixation holds the fragments. For internal fixation, locked T plate will be used.
    Primary Outcome Measure Information:
    Title
    assesment of accuracy of correction of high degree genu varum using this method of correction.
    Description
    assessment of mechanical axis deviation in degrees, mechanical tibiofemral angle in degrees, medial proximal tibial angle in degrees and the position of mechanical axis ratio. They are all measured in the immediate post operative long film and the long film after one year. The normal angles are known documented angles so, we will compare the preoperative and postoperative angles with the normal ones.Immediate postoperative long film on the lower limbs to compare pre and postoperative angles with the normal angles. Another long film is done after one year to follow up the achieved correction
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18years old or more Varus 20 degrees or more Exclusion Criteria: Contraindication to internal fixation Associated osteoarthritis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kerolos Maged, MBBCH
    Phone
    +2/01063692926
    Email
    Kerolosmaged230@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wael El Adly, MD
    Phone
    01224265850
    Email
    eladlyw@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7488273
    Citation
    Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1541-6. doi: 10.1002/art.1780381104.
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    Citation
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    PubMed Identifier
    3818700
    Citation
    Hernigou P, Medevielle D, Debeyre J, Goutallier D. Proximal tibial osteotomy for osteoarthritis with varus deformity. A ten to thirteen-year follow-up study. J Bone Joint Surg Am. 1987 Mar;69(3):332-54.
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    PubMed Identifier
    19823659
    Citation
    Tuli SM, Kapoor V. High tibial closing wedge osteotomy for medial compartment osteoarthrosis of knee. Indian J Orthop. 2008 Jan;42(1):73-7. doi: 10.4103/0019-5413.38585.
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    PubMed Identifier
    3782246
    Citation
    Sundaram NA, Hallett JP, Sullivan MF. Dome osteotomy of the tibia for osteoarthritis of the knee. J Bone Joint Surg Br. 1986 Nov;68(5):782-6. doi: 10.1302/0301-620X.68B5.3782246.
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    PubMed Identifier
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    Citation
    Rozbruch SR, Segal K, Ilizarov S, Fragomen AT, Ilizarov G. Does the Taylor Spatial Frame accurately correct tibial deformities? Clin Orthop Relat Res. 2010 May;468(5):1352-61. doi: 10.1007/s11999-009-1161-7. Epub 2009 Nov 13.
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    PubMed Identifier
    28656162
    Citation
    Kazemi SM, Qoreishi M, Behboudi E, Manafi A, Kazemi SK. Evaluation of Changes in the Tibiotalar joint after High Tibial Osteotomy. Arch Bone Jt Surg. 2017 May;5(3):149-152.
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    PubMed Identifier
    12851347
    Citation
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    PubMed Identifier
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    Citation
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    Results Reference
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    Citation
    Rozbruch SR. Fixator-assisted plating of limb deformities. Oper Tech Orthop. 2011;21:174-.
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    Citation
    Paley D. 1st ed. New York: Springer; 2002. Principles of deformity correction; pp. 175-94
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    External Fixator Assisted Genu Varum Correction

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