Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

External Fixator Assisted Genu Varum Correction

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: NCT03443648
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Kerolos Maged, Assiut University

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..

Condition or disease Intervention/treatment Phase
Deformity Procedure: External fixator assisted plaing Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fixator Assisted Plating for Correction of High Degree Genu Varum Deformity
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Intervention Details:
  • Procedure: External fixator assisted plaing
    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 Measures :
  1. assesment of accuracy of correction of high degree genu varum using this method of correction. [ Time Frame: one year ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Contraindication to internal fixation
  2. Associated osteoarthritis

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): NCT03443648


Contacts
Layout table for location contacts
Contact: Kerolos Maged, MBBCH +2/01063692926 Kerolosmaged230@gmail.com
Contact: Wael El Adly, MD 01224265850 eladlyw@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
Rozbruch SR. Fixator-assisted plating of limb deformities. Oper Tech Orthop. 2011;21:174-.
Paley D. 1st ed. New York: Springer; 2002. Principles of deformity correction; p 1-18.12.
Paley D. 1st ed. New York: Springer; 2002. Principles of deformity correction; pp. 175-94

Layout table for additonal information
Responsible Party: Kerolos Maged, Resident in the orhtopaedics and traumatology department, Assiut University
ClinicalTrials.gov Identifier: NCT03443648     History of Changes
Other Study ID Numbers: FAVC
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities
Genu Varum
Bone Diseases
Musculoskeletal Diseases