Clinical trial NCT03628664: Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
Official title: Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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?

Eligibility criteria: Inclusion Criteria:

* Advanced knee osteoarthritis in which total knee arthroplasty is indicated

Exclusion Criteria:

* Revision total knee arthroplasty

Primary outcomes:
measure: Knee Society score (KSS)
timeFrame: one year
measure: Western Ontario and McMaster university osteoarthritis index (WOMAC) score
timeFrame: One year
Secondary outcomes:
measure: Patient satisfaction: Knee Society score(KSS) subscale
timeFrame: one year
measure: Patellofemoral functional score
timeFrame: one year
measure: Revision rate
timeFrame: one year
measure: Knee range of motion
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Univrsity
Study officials:
affiliation: Ain Shams University
name: Ahmed Saeed Younis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Radwan Gamal Abdel Hamid, Dr.
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Mohamed Awad, Dr.
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Wael Samir Osman, professor
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Tarek Mohammed Samy, Professor
role: STUDY_CHAIR
References: