Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty (CT planning)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03628664
Recruitment Status : Unknown
Verified August 2018 by Ahmed Saeed Younis, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Saeed Younis, Ain Shams University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Total knee arthroplasty is one of the most common management methods of knee osteoarthritis. Patellar complications are one of the important causes of revision total knee arthroplasty. Proper placement of the components in the best rotational and axial alignment would achieve better patellar tracking and the best functional outcomes. Preoperative CT scan can add information regarding the coronal and rotational alignment of the prosthesis components.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Radiation: CT scan Not Applicable

Detailed Description:

Total knee arthroplasty is the gold standard treatment for advanced knee osteoarthritis. In spite of the great advance in the prosthesis design, surgical techniques and rehabilitation programs, only 85% (75% to 92%) of patients with total knee arthroplasty are satisfied with their operations and 30% develops patellofemoral complications.

Femoral and tibial components malrotation is a crucial cause of postoperative knee pain, patellar instability, and may lead to revision. In measured resection technique the surgical epicondylar axis (SEA) is the center of rotation of the knee and the femoral component must be parallel to this axis. The surgical epicondylar axis is difficult to be determined intraoperative by palpation.

Commonly, surgeons routinely set the femoral posterior condyle resection at three degrees fixed from the posterior condylar line (PCL) because the PCL was found to be three degrees internally rotated from the (SEA).

The posterior condylar angle on a three-dimensional structure reconstruction of the CT scans in osteoarthritic knees has also been shown as 3.3° ± 1.5°, However, another study documented the posterior condylar angle (PCA) in osteoarthritic knees as 1.6° ± 1.9°. Also there is a two to three degree difference between the surgical epicondylar axis and the anatomical epicondylar axis. Therefore, a routine bone resection of three degrees from the PCL is not universal for all cases and may create malrotation of the femur.

CT scan can provide an adequate template with good but not excellent inter and intra observer reliability for exact determination of the surgical epicondylar axis and femoral component rotation.

2. AIM/ OBJECTIVES

  1. What is the mean of distal femoral rotation in Egyptian population?
  2. What is the effect of osteoarthritis on femoral rotation?
  3. How much is the accuracy of CT scan in detecting anatomical landmarks to choose the intraoperative femoral component rotation (correlation between radiological and intraoperative findings?
  4. Is the relation between the anatomical epicondylar axis (AEA) in comparison to surgical epicondylar axis (SEA) a fixed ratio?
  5. What is the relation between thde femoral component malrotation and the coronal alignment and flexion gap balance?
  6. Can CT scan add a simple planning tool for accurate placement of femoral component and the reproducibility of the preoperative plan in surgery?
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: CT planned total knee arthroplasty
Surgeon will follow the CT plan
 Radiation: CT scan
Assessment of the actual posterior condylar angle using the CT scan
No Intervention: Non CT planned total knee arthroplasty
Surgeon will not follow the CT plan


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Knee Society score (KSS) [ Time Frame: one year ]
  2. Western Ontario and McMaster university osteoarthritis index (WOMAC) score [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Patient satisfaction: Knee Society score(KSS) subscale [ Time Frame: one year ]
    Knee Society score(KSS) subscale satisfaction

  2. Patellofemoral functional score [ Time Frame: one year ]
    Barlett patellofemoral score

  3. Revision rate [ Time Frame: one year ]
    Number of patients undergoing revision knee arthroplasty surgery

  4. Knee range of motion [ Time Frame: one year ]
    Knee range of motion (flexion and extension)in degrees


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced knee osteoarthritis in which total knee arthroplasty is indicated

Exclusion Criteria:

  • Revision total knee arthroplasty
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03628664


Contacts
Layout table for location contacts
Contact: Ahmed Saeed Younis, Dr. 201012370677 ahmed.s.younis@med.asu.edu.eg
Contact: Radwan Gamal Abdel Hamid, Dr. 201272221906 dr_radwan05@yahoo.com

Locations
Layout table for location information
Egypt
Ain Shams Univrsity
Cairo, Egypt, 11566
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed Saeed Younis, Dr. Ain Shams University
Study Director: Radwan Gamal Abdel Hamid, Dr. Ain Shams University
Study Director: Mohamed Awad, Dr. Ain Shams University
Study Chair: Wael Samir Osman, professor Ain Shams University
Study Chair: Tarek Mohammed Samy, Professor Ain Shams University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed Saeed Younis, Clinical investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03628664    
Other Study ID Numbers: 44556677
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases