Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.

Official Title
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Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a male or non-pregnant female between the ages of 21-80. Patient requires cemented primary total knee replacement. Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA) or avascular necrosis (AVN). Patient has intact collateral ligaments. Patient has signed and dated an IRB approved study specific consent form. Patient is able and willing to participate in the study according to the protocol for the full length of the expected term of follow-up, and to follow their physician's directions. Patient has failed to respond to conservative treatment modalities. Exclusion Criteria: Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee. Patient is morbidly obese, >60% over ideal body weight for frame and height. Patient has a deformity at the involved knee greater than 45 degrees of flexion, 45 degrees of varus or 45 degrees of valgus. Patient has an active or suspected latent infection in or about the knee joint. Patient has a malignancy in the area of the involved knee joint. Patient has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. Patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period. Female patient is or plans to become pregnant during the course of the study. Patient has a known sensitivity to device materials. Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mini-midvastus approach<br>Mini Midvastus approach with skin incision less than 13 cm long and vastus medialis obliquus dissection not more than 3 cm from the patellar margin was used to perform total knee arthroplasty in 40 patients. | Procedure: Total knee arthroplasty<br>* staged bilateral total knee arthroplasty (not more than 7 days between surgeries)<br>* Other names: Stryker Triathlon posterior stabilized components;|
| Active Comparator: Medial Parapatellar Approach<br>Mini Medial Parapatellar approach with skin incision less than 13 cm. The extension into quadriceps tendon did not exceed 3 cm.Mini medial parapatellar approach was used to perform total knee arthroplasty. | Procedure: Total knee arthroplasty<br>* staged bilateral total knee arthroplasty (not more than 7 days between surgeries)<br>* Other names: Stryker Triathlon posterior stabilized components;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score | The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps Strength |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty