Knee OsteoarthritisCT planningNCT03628664
Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
A study testing CT scan in people with Knee Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Advanced knee osteoarthritis in which total knee arthroplasty is indicated
Who cannot join
- Revision total knee arthroplasty
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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?
- Conditions
- Knee Osteoarthritis
- Being tested
- CT scan
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
Assessment of the actual posterior condylar angle using the CT scan
| Study group | Role | What they receive |
|---|---|---|
| CT planned total knee arthroplasty | Active comparator | Surgeon will follow the CT plan Receives: Radiation: CT scan |
| Non CT planned total knee arthroplasty | No intervention | Surgeon will not follow the CT plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society score (KSS)
Measured: one year
Western Ontario and McMaster university osteoarthritis index (WOMAC) score
Measured: One year
Secondary outcomes (4)
Patient satisfaction: Knee Society score(KSS) subscale
Knee Society score(KSS) subscale satisfaction
Measured: one year
Patellofemoral functional score
Barlett patellofemoral score
Measured: one year
Revision rate
Number of patients undergoing revision knee arthroplasty surgery
Measured: one year
Knee range of motion
Knee range of motion (flexion and extension)in degrees
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saeed Younis, Ain Shams University
- Investigators
- Ahmed Saeed Younis, Dr., Principal investigator, Ain Shams UniversityRadwan Gamal Abdel Hamid, Dr., Study director, Ain Shams UniversityMohamed Awad, Dr., Study director, Ain Shams UniversityWael Samir Osman, professor, Study chair, Ain Shams UniversityTarek Mohammed Samy, Professor, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628664
- Sponsor's protocol ID
- 44556677
- Acronym
- CT planning
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative CT Assisted Planning for Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03628664
- Acronym / sponsor ID
- CT planning / 44556677
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT planned total knee arthroplasty | Active comparator | Radiation: CT scanSurgeon will follow the CT plan |
| Non CT planned total knee arthroplasty | No intervention | –Surgeon will not follow the CT plan |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced knee osteoarthritis in which total knee arthroplasty is indicated
Key exclusion criteria (1 listed)
- Revision total knee arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT scanAssessment of the actual posterior condylar angle using the CT scan | Radiation | CT planned total knee arthroplasty |
Primary outcome
Knee Society score (KSS)
Time frame: one year
Western Ontario and McMaster university osteoarthritis index (WOMAC) score
Time frame: One year
4 secondary outcomes
Patient satisfaction: Knee Society score(KSS) subscale
Time frame: one year
Patellofemoral functional score
Time frame: one year
Revision rate
Time frame: one year
Knee range of motion
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Saeed Younis, Dr. principal investigator
Ain Shams University
Radwan Gamal Abdel Hamid, Dr. study director
Ain Shams University
Mohamed Awad, Dr. study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Knee Osteoarthritis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Saeed Younis, Dr. (201012370677, ahmed.s.younis@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society score (KSS) (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.