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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CT scan
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced knee osteoarthritis in which total knee arthroplasty is indicated

Exclusion Criteria:

  • Revision total knee arthroplasty

Sites / Locations

  • Ain Shams Univrsity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CT planned total knee arthroplasty

Non CT planned total knee arthroplasty

Arm Description

Surgeon will follow the CT plan

Surgeon will not follow the CT plan

Outcomes

Primary Outcome Measures

Knee Society score (KSS)
Western Ontario and McMaster university osteoarthritis index (WOMAC) score

Secondary Outcome Measures

Patient satisfaction: Knee Society score(KSS) subscale
Knee Society score(KSS) subscale satisfaction
Patellofemoral functional score
Barlett patellofemoral score
Revision rate
Number of patients undergoing revision knee arthroplasty surgery
Knee range of motion
Knee range of motion (flexion and extension)in degrees

Full Information

First Posted
July 25, 2018
Last Updated
August 10, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03628664
Brief Title
Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
Acronym
CT planning
Official Title
Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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 What is the mean of distal femoral rotation in Egyptian population? What is the effect of osteoarthritis on femoral rotation? 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? Is the relation between the anatomical epicondylar axis (AEA) in comparison to surgical epicondylar axis (SEA) a fixed ratio? What is the relation between thde femoral component malrotation and the coronal alignment and flexion gap balance? Can CT scan add a simple planning tool for accurate placement of femoral component and the reproducibility of the preoperative plan in surgery?

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT planned total knee arthroplasty
Arm Type
Active Comparator
Arm Description
Surgeon will follow the CT plan
Arm Title
Non CT planned total knee arthroplasty
Arm Type
No Intervention
Arm Description
Surgeon will not follow the CT plan
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
Assessment of the actual posterior condylar angle using the CT scan
Primary Outcome Measure Information:
Title
Knee Society score (KSS)
Time Frame
one year
Title
Western Ontario and McMaster university osteoarthritis index (WOMAC) score
Time Frame
One year
Secondary Outcome Measure Information:
Title
Patient satisfaction: Knee Society score(KSS) subscale
Description
Knee Society score(KSS) subscale satisfaction
Time Frame
one year
Title
Patellofemoral functional score
Description
Barlett patellofemoral score
Time Frame
one year
Title
Revision rate
Description
Number of patients undergoing revision knee arthroplasty surgery
Time Frame
one year
Title
Knee range of motion
Description
Knee range of motion (flexion and extension)in degrees
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced knee osteoarthritis in which total knee arthroplasty is indicated Exclusion Criteria: Revision total knee arthroplasty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Saeed Younis, Dr.
Phone
201012370677
Email
ahmed.s.younis@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Radwan Gamal Abdel Hamid, Dr.
Phone
201272221906
Email
dr_radwan05@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Saeed Younis, Dr.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radwan Gamal Abdel Hamid, Dr.
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Awad, Dr.
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wael Samir Osman, professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tarek Mohammed Samy, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams Univrsity
City
Cairo
ZIP/Postal Code
11566
Country
Egypt

12. IPD Sharing Statement

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Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty

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