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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quads-Sparing Approach with Tourniquet | Experimental | Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet. |
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| Medial Para-Patellar with Tourniquet | Active Comparator | 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. |
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| Quads-Sparing Approach w/o Tourniquet | Active Comparator | Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet. |
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| Medial Para-Patellar w/o Tourniquet | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quads-Sparing Approach | Procedure | Quadriceps-sparing mid-vastus approach for total knee arthroplasty |
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| Measure | Description | Time Frame |
|---|---|---|
| Indirect and Direct Costs of Treatment | ER visits, clinician visits, caregiver lost productivity, tests, etc. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numeric Rating Scale | Pain | 1 year |
| Short Form - 12 (SF-12) | Quality of Life | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent A Lanting, MD | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A5A5 | Canada |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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Participants will not be told which group they have been assigned to until they have reached the final follow-up visit for the study.
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| Medial Para-Patellar Approach | Procedure | Medial para-patellar approach for total knee arthroplasty |
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| 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 |
| D012216 |
| Rheumatic Diseases |