An interventional study of Quads-Sparing Approach and Medial Para-Patellar Approach in Knee Osteoarthritis and Knee Arthroplasty, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 83 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
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Exclusion Criteria:
Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet.
Procedure: Quads-Sparing Approach
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
Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet.
Procedure: Quads-Sparing Approach
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
Quadriceps-sparing mid-vastus approach for total knee arthroplasty
Also known as: quads-sparing
Medial para-patellar approach for total knee arthroplasty
Also known as: standard
Indirect and Direct Costs of Treatment
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Time frame: 1 year
Pain Numeric Rating Scale
Pain
Time frame: 1 year
Short Form - 12 (SF-12)
Quality of Life
Time frame: 1 year
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Functional Outcome
Time frame: 1 year
Knee Society Score (KSS)
Functional Outcome
Time frame: 1 year
EuroQol-5D (EQ-5D)
Quality of Life
Time frame: 1 year
Timed Up and Go Test
Function
Time frame: 1 year
Adverse events
Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Time frame: 1 year
Caregiver Assistance Scale
Caregiver Confidence
Time frame: 6 weeks
Caregiver Strain Index
Caregiver Strain
Time frame: 6 weeks
Patient Satisfaction Questionnaire
Patient satisfaction
Time frame: 2 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's