PSI for Bilateral Simultaneous TKA in Sever Varus

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Patient specific instrument; Other: conventional technique for TKA

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • October Six city, Egypt
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TKA using PSI; Total Knee Arthroplasty using Patient Specific Instrument	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; Other Names: PSI
EXPERIMENTAL: 2 TKA using conditional technique.; Total Knee Arthroplasty using conditional technique.	Other: conventional technique for TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
functional score	up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood transfusion rate	up to 52 weeks
complication rate	up to 52 weeks
hospital stay	up to 52 weeks
Operative time	during surgery

Collaborators and Investigators

• Sponsor: October 6 University
• Investigators: Study Chair: Mohamed El Sayed, Dr, Bone and Joint Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): September 1, 2013
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: November 16, 2013
• First Submitted That Met QC Criteria: November 23, 2013
• First Posted (ESTIMATE): November 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 23, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: PSI: Patient Specific Instrument; TKA: Total Knee Arthroplasty; Articular Deformity; Varus
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: October6U-0002