Quadriceps Sparing Versus Standard Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study is a randomized clinical trial comparing standard medial para-patellar total knee arthroplasty with a quadriceps sparing mid-vastus approach. Patients who are medically well and have a good support structure at home will be randomized to a standard or quadriceps sparing surgical approach stratified by type of analgesia (adductor canal block or local infiltration). We will compare patient satisfaction and costs from the perspective of the Ministry of Health, the institution, society and the patient.

Detailed Description
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Over the past 20 years the length of stay in hospital after total knee replacements has decreased from 9 days to 3 days in Canada and in just the last 10 years the mean length of stay has decreased by half from 6 to 3 days. In order to discharge patients quicker from hospital it's been theorized that less invasive techniques and better, longer lasting anaesthesia are required. The less invasive quadriceps sparing mid-vastus approach for TKA has been compared to the standard medial para-patellar technique in many studies. Meta-analyses that have looked at studies comparing these approaches have shown some early advantages for quadriceps sparing early post-surgery, but no differences between groups later on and no difference in complications. Early advantages of the mid-vastus approach could potentially allow for earlier and safer discharge from hospital. Adductor canal block (ACB) and local infiltration analgesia (LIA) form the mainstay of opioid sparing multimodal analgesia for TKA. The nerves of the adductor canal innervate the superficial and deep tissues of the anterior and medial aspects of the knee. ACB has been shown to provide equivalent analgesia while maintaining quadriceps power compared to femoral nerve block (FNB). LIA involves infiltrating the soft tissues of the posterior, lateral and medial aspects of the knee with local anesthetics, ketorolac and morphine. Due to their minimal impact on motor function, ACB and LIA are suitable for fast track TKA. In combination, quadriceps sparing mid-vastus TKA with ACB may allow patients to be discharged from hospital quicker when compared with standard medial para-patellar TKA with LIA. With our study we aim to investigate whether a quadriceps sparing TKA can provide cost savings without changing complication rates when compared to the current standard of care.

Official Title
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Cost and Patient Satisfaction After Total Knee Arthroplasty: Standard Medial Para-patellar Versus Quadriceps Sparing Mid-vastus Surgical Approach

Conditions
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Knee Osteoarthritis, Knee Arthroplasty

Intervention / Treatment
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* Procedure: Quads-Sparing Approach
* Procedure: Medial Para-Patellar Approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients requiring primary total knee replacement patients willing and able to comply with follow-up requirements and self-evaluations patients willing to sign an IRB approved informed consent form English fluency (printed instructions are provided in English only) varus arthropathy osteoarthritis ASA less than or equal to 3 home/cell phone access adult to accompany patient home post-operatively and to stay with patient for a minimum period of 1-2 days Exclusion Criteria: patients with inflammatory arthritis patients with a BMI greater than 40 or less than 18 patients who are skeletally immature patient with an active infection or suspected latent infection in or about the joint bone stock that is inadequate for support or fixation of the prosthesis hardware precluding intramedullary instrumentation prior osteotomies of the femur or tibia patients living greater than 1.5 hours from the hospital patients without access to caregivers, or unable to go to their home after surgery cognitive or neuromotor conditions patient has significant pain management issues patient/family history of anaesthesia related complications (e.g. malignant hypothermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea) significant psycho/social issues that would prevent the patient from managing at home safely

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Participants will be randomized to undergo their surgery through either the quadriceps-sparing mid-vastus approach or the medial para-patellar approach and with or without a tourniquet. We will stratify based on which type of analgesia will be used post-surgery, either an adductor canal block or local infiltration.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quads-Sparing Approach with Tourniquet<br>Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet. | Procedure: Quads-Sparing Approach<br>* Quadriceps-sparing mid-vastus approach for total knee arthroplasty<br>* Other names: quads-sparing;|
| Active Comparator: Medial Para-Patellar with Tourniquet<br>Participants will undergo total knee arthroplasty with a medial para-patellar approach and a tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery. | Procedure: Medial Para-Patellar Approach<br>* Medial para-patellar approach for total knee arthroplasty<br>* Other names: standard;|
| Active Comparator: Quads-Sparing Approach w/o Tourniquet<br>Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet. | Procedure: Quads-Sparing Approach<br>* Quadriceps-sparing mid-vastus approach for total knee arthroplasty<br>* Other names: quads-sparing;|
| Active Comparator: Medial Para-Patellar w/o Tourniquet<br>Participants will undergo total knee arthroplasty with a medial para-patellar approach and no tourniquet. An intramedullary femoral guide and extramedullary tibial guide will be used during the surgery. | Procedure: Medial Para-Patellar Approach<br>* Medial para-patellar approach for total knee arthroplasty<br>* Other names: standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirect and Direct Costs of Treatment | ER visits, clinician visits, caregiver lost productivity, tests, etc. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Numeric Rating Scale | Pain | 1 year | 
| Short Form - 12 (SF-12) | Quality of Life | 1 year | 
| Western Ontario McMaster Osteoarthritis Index (WOMAC) | Functional Outcome | 1 year | 
| Knee Society Score (KSS) | Functional Outcome | 1 year | 
| EuroQol-5D (EQ-5D) | Quality of Life | 1 year | 
| Timed Up and Go Test | Function | 1 year | 
| Adverse events | Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc. | 1 year | 
| Caregiver Assistance Scale | Caregiver Confidence | 6 weeks | 
| Caregiver Strain Index | Caregiver Strain | 6 weeks | 
| Patient Satisfaction Questionnaire | Patient satisfaction | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar