PSI for Bilateral Simultaneous TKA in Sever Varus

Knee Osteoarthritis Clinical Trial

Official title:

Bilateral Simultaneous Total Knee Arthroplasty in Patients With Severe Articular Deformities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998321
• Other study ID #: October6U-0002
• Status: Completed
• Phase: N/A
• First received: November 16, 2013
• Last updated: November 23, 2013
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Deformity ranging from 5 to 30 varus,

• 10-40 valgus,

• fixed flexion deformity from 5 to 50

• wellness to participate in the study

Exclusion Criteria:

• absence of deformities varus, valgus, or flexion deformity

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Patient specific instrument
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 TKA

Locations

Country	Name	City	State
Egypt	October 6 University	October Six city

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional score		up to 52 weeks	Yes
Secondary	Blood transfusion rate		up to 52 weeks	Yes
Secondary	complication rate		up to 52 weeks	Yes
Secondary	hospital stay		up to 52 weeks	Yes
Secondary	Operative time		during surgery	Yes