Outcome of TKA Using Customized Cutting Block Compared With Conventional Intramedullary Cutting Guide

Study Overview
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Brief Summary
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Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of OA knee patients.

Detailed Description
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Customized cutting block and conventional cutting guide are both effective in improving accuracy and function of osteoarthritic knee patients.

Official Title
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Comparison of Customized Cutting Block (Visionaire™) and Conventional Total Knee Arthroplasty: A Prospective Randomized Control Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Patient specific cutting guides
* Procedure: Standard knee cutting guides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60-90 Diagnosis of osteoarthritis or rheumatoid arthritis of the knee and qualify for surgery, as indicated by one of the following: Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved; Correction of varus or valgus. Willing to participate and return for follow-up study visits. Exclusion Criteria: Vascular insufficiency Previous deep vein thrombosis and pulmonary embolism Previous osteotomy Previous patella fracture or surgery Previous healed tibia or femur fractures Previous joint replacement surgery

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard knee cutting guides<br>Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod. | Procedure: Standard knee cutting guides<br>* Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.<br>|
| Active Comparator: Patient specific cutting guides<br>Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone. | Procedure: Patient specific cutting guides<br>* Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Axis Alignment (Absolute Value Measured in Degrees) Using 3 Feet Long Leg Films | Femoral Valgus Angle, Tibial varus angle, Tibial slope, Femoral Flexsion/Extension angle, Implant Rotation | 3 Months Post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Bleeding |  | Intra-operative | 
| Operative time |  | During the procedure | 
| Blood volume in suction drain |  | Post-operative Day 2 | 
| Hemoglobin level |  | Post-operative day1, 2, 3 | 
| WOMAC score |  | 6 weeks | 
| WOMAC score |  | 3 Months | 
| WOMAC score |  | 6 Months | 
| WOMAC score |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis, Total Knee Arthroplasty, Customized Cutting Block, Conventional Intramedullary Cutting Guide