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Quadriceps Sparing Versus Standard Total Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03081663
Enrollment
83
Registered
2017-03-16
Start date
2017-07-11
Completion date
2021-12-16
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty, Knee Osteoarthritis

Keywords

total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar

Brief summary

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

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.

Interventions

PROCEDUREMedial Para-Patellar Approach

Medial para-patellar approach for total knee arthroplasty

PROCEDUREQuads-Sparing Approach

Quadriceps-sparing mid-vastus approach for total knee arthroplasty

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants will not be told which group they have been assigned to until they have reached the final follow-up visit for the study.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Indirect and Direct Costs of Treatment1 yearER visits, clinician visits, caregiver lost productivity, tests, etc.

Secondary

MeasureTime frameDescription
Short Form - 12 (SF-12)1 yearQuality of Life
Western Ontario McMaster Osteoarthritis Index (WOMAC)1 yearFunctional Outcome
Knee Society Score (KSS)1 yearFunctional Outcome
EuroQol-5D (EQ-5D)1 yearQuality of Life
Pain Numeric Rating Scale1 yearPain
Adverse events1 yearFalls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Caregiver Assistance Scale6 weeksCaregiver Confidence
Caregiver Strain Index6 weeksCaregiver Strain
Patient Satisfaction Questionnaire2 weeksPatient satisfaction
Timed Up and Go Test1 yearFunction

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026