The Subvastus Approach in Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to determine if the observed benefits of minimally invasive total knee arthroplasty, namely decreased hospital stay and increased range of motion, can be achieved with standard knee arthroplasty using the subvastus approach.

Official Title
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The Subvastus Approach in Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Surgical approach for total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You are willing to take part in the study, including signing this form after carefully reading it. You are available for follow-up for a minimum of 24 months (2 years). You have no medical conditions that prevent you from having surgery. This is the primary (first) knee replacement for this knee You are fluent in English and are able to understand your responsibilities in this study. Exclusion Criteria: Active, local or systemic infection Fibromyalgia or other chronic pain syndrome Inability to follow the study requirements Had this knee replaced before Had a previous surgery on this knee that would interfere with the MIS approach (examples are femoral-femoral bypass, femoral-popliteal bypass, and quadricepsplasty) Body Mass Index (BMI) > 35, as you would not be eligible for the MIS approach.
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>minimally invasive incision | Procedure: Surgical approach for total knee arthroplasty<br>* total knee arthroplasty surgery using minimally invasive surgery or standard technique.<br>|
| Active Comparator: Standard<br>Standard incision length | Procedure: Surgical approach for total knee arthroplasty<br>* total knee arthroplasty surgery using minimally invasive surgery or standard technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Post Operative | 
| Range of motion at discharge and six weeks post-operatively |  | Discharge and six weeks post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complications |  | post operative until wound healed | 
| Post-operative narcotic use |  | 24 months post operative | 
| Post-operative blood loss |  | Post operative | 
| The ability to straight-leg raise at two and twenty-four hours post-operatively |  | 2 and 24 hours post operative | 
| Knee Society Clinical Rating Scale |  | pre-op, 6 months, 12 months, and 24 months post operative | 
| SF-12 |  | pre-op, 6 months, 12 months, and 24 months post operative | 
| WOMAC. |  | pre-op, 6 months, 12 months, and 24 months post operative |