Knee OsteoarthritisNCT01998321
PSI for Bilateral Simultaneous TKA in Sever Varus
A study testing Patient specific instrument and conventional technique for TKA in people with Knee Osteoarthritis, run by October 6 University at 1 site in Egypt.
Trial summary
the Purpose of this study was to evaluate the short term outcome of patient specific instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee osteoarthritis with sever varus Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient specific instrument and conventional technique for TKA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2012to Sep 2013
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deformity ranging from 5 to 30 varus,
- 10-40 valgus,
- fixed flexion deformity from 5 to 50
- wellness to participate in the study
Who cannot join
- absence of deformities varus, valgus, or flexion deformity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Simultaneous Total Knee Arthroplasty in Patients With Severe Articular Deformities
the Purpose of this study was to evaluate the short term outcome of patient specific instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee osteoarthritis with sever varus
Read the detailed description
The incidence of knee Osteoarthritis is variable and it is very high in Far East 47.0% and 70.2% in men and women respectively, while it is 17.2% and 82.8% in male and females respectively in Middle East. The incidence of bilateral knee Osteoarthritis is 48%. TKA is the standard treatment for Osteoarthritis. Many authors prefer bilateral simultaneous TKA can be performed for straight forward cases of Knee Osteoarthritis, although it has higher complication rate that could be discouraging.
Knee Osteoarthritis could be associated with articular deformities such as varus, valgus, flexion deformity and rarely recurvatum. These deformities could be associated with bone loss, ligamentous laxity, leg length discrepancy, bilateral shortening and disfigurement. These deformities need to be corrected during TKA and this make the procedure more difficult especially in severe cases with associated problems as described above. Some patients with knee Osteoarthritis present late when the condition becomes bilateral with sever articular deformity. Late presentation is a common feather in developing countries and low income countries and also in Middle and Far East.
With the progression of Knee Osteoarthritis patient's condition deteriorates gradually, both local and generally with increasing loss of cartilage and bone leading to deformities and joint laxity. This general condition with the increasing disability leads to high risk of associated obesity and comorbidities. The late presentation is multifactorial and complex to explain. There are obvious reasons such as economic constrain, late referral, lake of experienced surgeons and high demand and expectation such as full flexion in Middle and Far East. There are other unexplained reasons such as fear of surgeries, misconception about TKA and psychological factors.
Unilateral TKA for patients with bilateral knee Osteoarthritis with sever articular deformities is not beneficial to the patients, as it does not allow correction of the deformities and easier rehabilitation, and may not be satisfying for the patient because patient left with a straight knee after TKA and a deformed knee in the other side that leads to difficult rehabilitation and may force the TKA to get the same deformity to adapt to the other knee. With this dissatisfaction the patient may refuse to have the other knee done.
Bilateral simultaneous TKA in patient with sever articular deformities is beneficial to the patients as it allows correction of the deformities and easier rehabilitation.
However bilateral simultaneous TKA for such complex cases is a very demanding procedure and could be associated with a higher rate of complications such as fat embolism , mortality, infection, bleeding, deep venous thrombosis, and general complications.
PSI could be useful for bilateral simultaneous TKA because it eliminates the use of intramedullary guides and may reduce operative time, bleeding and risk of complications such as fat embolism or infection.
The aim of this study is to review the outcome of using PSI in bilateral simultaneous TKA for patient with sever articular deformities which is common in middle east region.
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient specific instrument, conventional technique for TKA
- Keywords
- PSI: Patient Specific Instrument, TKA: Total Knee Arthroplasty, Articular Deformity, Varus
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient specific instrumentOther
Also called PSI
A special software with the ability to perform 3D planning including sizing, alignment, bone cutting, positioning of implants, simulation \& PSI designing and PSI production
conventional technique for TKAOther
| Study group | Role | What they receive |
|---|---|---|
| TKA using PSI | Experimental | Total Knee Arthroplasty using Patient Specific Instrument Receives: Other: Patient specific instrument |
| 2 TKA using conditional technique. | Experimental | Total Knee Arthroplasty using conditional technique. Receives: Other: conventional technique for TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional score
Measured: up to 52 weeks
Secondary outcomes (4)
Blood transfusion rate
Measured: up to 52 weeks
complication rate
Measured: up to 52 weeks
hospital stay
Measured: up to 52 weeks
Operative time
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
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.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, October 6 University
- Investigators
- Mahmoud A Hafez, Professor, Principal investigator, October 6 UniversityMohamed El Sayed, Dr, Study chair, Bone and Joint Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998321
- Sponsor's protocol ID
- October6U-0002
- Status last verified
- Nov 2013
- First submitted
- 16 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Simultaneous Total Knee Arthroplasty in Patients With Severe Articular Deformities
- ClinicalTrials.gov ID
- NCT01998321
- Acronym / sponsor ID
- October6U-0002
- Conditions
- Knee Osteoarthritis
- Keywords
- PSI: Patient Specific Instrument, TKA: Total Knee Arthroplasty, Articular Deformity, Varus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
the Purpose of this study was to evaluate the short term outcome of patient specific instrument (PSI) in cases of bilateral simultaneous total knee arthroplasty (TKA) for knee osteoarthritis with sever varus
Detailed description
The incidence of knee Osteoarthritis is variable and it is very high in Far East 47.0% and 70.2% in men and women respectively, while it is 17.2% and 82.8% in male and females respectively in Middle East. The incidence of bilateral knee Osteoarthritis is 48%. TKA is the standard treatment for Osteoarthritis. Many authors prefer bilateral simultaneous TKA can be performed for straight forward cases of Knee Osteoarthritis, although it has higher complication rate that could be discouraging.
Knee Osteoarthritis could be associated with articular deformities such as varus, valgus, flexion deformity and rarely recurvatum. These deformities could be associated with bone loss, ligamentous laxity, leg length discrepancy, bilateral shortening and disfigurement. These deformities need to be corrected during TKA and this make the procedure more difficult especially in severe cases with associated problems as described above. Some patients with knee Osteoarthritis present late when the condition becomes bilateral with sever articular deformity. Late presentation is a common feather in developing countries and low income countries and also in Middle and Far East.
With the progression of Knee Osteoarthritis patient's condition deteriorates gradually, both local and generally with increasing loss of cartilage and bone leading to deformities and joint laxity. This general condition with the increasing disability leads to high risk of associated obesity and comorbidities. The late presentation is multifactorial and complex to explain. There are obvious reasons such as economic constrain, late referral, lake of experienced surgeons and high demand and expectation such as full flexion in Middle and Far East. There are other unexplained reasons such as fear of surgeries, misconception about TKA and psychological factors.
Unilateral TKA for patients with bilateral knee Osteoarthritis with sever articular deformities is not beneficial to the patients, as it does not allow correction of the deformities and easier rehabilitation, and may not be satisfying for the patient because patient left with a straight knee after TKA and a deformed knee in the other side that leads to difficult rehabilitation and may force the TKA to get the same deformity to adapt to the other knee. With this dissatisfaction the patient may refuse to have the other knee done.
Bilateral simultaneous TKA in patient with sever articular deformities is beneficial to the patients as it allows correction of the deformities and easier rehabilitation.
However bilateral simultaneous TKA for such complex cases is a very demanding procedure and could be associated with a higher rate of complications such as fat embolism , mortality, infection, bleeding, deep venous thrombosis, and general complications.
PSI could be useful for bilateral simultaneous TKA because it eliminates the use of intramedullary guides and may reduce operative time, bleeding and risk of complications such as fat embolism or infection.
The aim of this study is to review the outcome of using PSI in bilateral simultaneous TKA for patient with sever articular deformities which is common in middle east region.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA using PSI | Experimental | Other: Patient specific instrumentTotal Knee Arthroplasty using Patient Specific Instrument |
| 2 TKA using conditional technique. | Experimental | Other: conventional technique for TKATotal Knee Arthroplasty using conditional technique. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Deformity ranging from 5 to 30 varus,
- 10-40 valgus,
- fixed flexion deformity from 5 to 50
- wellness to participate in the study
Key exclusion criteria (1 listed)
- absence of deformities varus, valgus, or flexion deformity
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 |
|---|---|---|
| Patient specific instrumentAlso: PSIA special software with the ability to perform 3D planning including sizing, alignment, bone cutting, positioning of implants, simulation \& PSI designing and PSI production | Other | TKA using PSI |
| conventional technique for TKA | Other | 2 TKA using conditional technique. |
Primary outcome
functional score
Time frame: up to 52 weeks
4 secondary outcomes
Blood transfusion rate
Time frame: up to 52 weeks
complication rate
Time frame: up to 52 weeks
hospital stay
Time frame: up to 52 weeks
Operative time
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Mahmoud A Hafez, Professor principal investigator
October 6 University
Mohamed El Sayed, Dr study chair
Bone and Joint Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient specific instrument and conventional technique for TKA in people with Knee Osteoarthritis, run by October 6 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 4 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: finished, as of the sponsor's last update on 28 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional score (time frame: up to 52 weeks). 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 28 Nov 2013.