Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

Study Overview
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Brief Summary
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Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis. Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Detailed Description
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Study executed with 3 centers and 69 patients.

Official Title
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A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: surgery method using CR TKP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient requiring Total Knee Arthroplasty (TKA) patients with Osteo arthritis intact collateral ligaments and patella tendon patients willing and able to comply with the post-operative schedule Exclusion Criteria: patients who require a revision TKA patients with TKA contralateral knee within 6 months with bad outcomes patients who need a TKA on contralateral side within 2 years intraoperative resurfacing of patella intraoperative eversion of patella patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy BMI > 30 patients with fixed flexion contracture> 15 degrees patients with deformity greater than 20 degrees of varus or 15 degrees of valgus Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy patient with Rheumatoid arthritis patient with systemic disease that would effect subject's wellfare or overall outcome of the study patient with other severe concurrent joint involvement which can effect their outcome patients with an immobile hip patient with a history of Pulmonary embolism or Deep venous thrombosis

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIS<br>Minimal invasive surgery for placement total knee prosthesis | Procedure: surgery method using CR TKP<br>* Operation through minimal invasive surgery or standard open surgery<br>* Other names: Cruciate retaining (CR total knee prosthesis (TKP) Stryker;|
| Active Comparator: conventional approach<br>conventional open surgery for placement total knee prosthesis. | Procedure: surgery method using CR TKP<br>* Operation through minimal invasive surgery or standard open surgery<br>* Other names: Cruciate retaining (CR total knee prosthesis (TKP) Stryker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion | measurement of flexion and extension in degrees | pre-op vs post-op until 5 years post-op | 
| blood loss | measurement of milliliters blood loss during the first 24 hours after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient questionnaire | WOMAC pain and function score | pre-op vs post-op until 5 year post operative | 
| chair rise and stair climb test | Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities | pre-op vs post-op until 5 years post operative |