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
About this trial
This is an interventional treatment trial for Deformity
Eligibility Criteria
Inclusion Criteria:
- Age 18years old or more
- Varus 20 degrees or more
Exclusion Criteria:
- Contraindication to internal fixation
- 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
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
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Citation
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Citation
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Citation
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Citation
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External Fixator Assisted Genu Varum Correction
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