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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Radiation: CT scan

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Saeed Younis, Dr.; Phone Number: 201012370677; Email: ahmed.s.younis@med.asu.edu.eg
• Study Contact Backup: Name: Radwan Gamal Abdel Hamid, Dr.; Phone Number: 201272221906; Email: dr_radwan05@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Ain Shams Univrsity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced knee osteoarthritis in which total knee arthroplasty is indicated

Exclusion Criteria:

• Revision total knee arthroplasty

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Knee Society score (KSS)	one year
Western Ontario and McMaster university osteoarthritis index (WOMAC) score	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ahmed Saeed Younis, Dr., ain shams University; Study Chair: Wael Samir Osman, professor, ain shams University; Study Director: Radwan Gamal Abdel Hamid, Dr., ain shams University; Study Director: Mohamed Awad, Dr., ain shams University; Study Chair: Tarek Mohammed Samy, Professor, ain shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 44556677

Drug and device information, study documents

• 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