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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Arthroplasty
• Intervention / Treatment: Procedure: Quads-Sparing Approach; Procedure: Medial Para-Patellar Approach

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quads-Sparing Approach with Tourniquet; Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet.	Procedure: Quads-Sparing Approach; Quadriceps-sparing mid-vastus approach for total knee arthroplasty; Other Names: quads-sparing
Active Comparator: Medial Para-Patellar with Tourniquet; 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; Medial para-patellar approach for total knee arthroplasty; Other Names: standard
Active Comparator: Quads-Sparing Approach w/o Tourniquet; Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet.	Procedure: Quads-Sparing Approach; Quadriceps-sparing mid-vastus approach for total knee arthroplasty; Other Names: quads-sparing
Active Comparator: Medial Para-Patellar w/o Tourniquet; 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; Medial para-patellar approach for total knee arthroplasty; Other Names: standard

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Brent A Lanting, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: total knee arthroplasty; quadriceps sparing mid-vastus; medial para-patellar
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 108949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No