Quadriceps Sparing Versus Standard Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081663
• Other study ID #: 108949
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: December 16, 2021

Study information

• Verified date: April 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Quads-Sparing Approach
Quadriceps-sparing mid-vastus approach for total knee arthroplasty
• Medial Para-Patellar Approach
Medial para-patellar approach for total knee arthroplasty

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indirect and Direct Costs of Treatment	ER visits, clinician visits, caregiver lost productivity, tests, etc.	1 year
Secondary	Pain Numeric Rating Scale	Pain	1 year
Secondary	Short Form - 12 (SF-12)	Quality of Life	1 year
Secondary	Western Ontario McMaster Osteoarthritis Index (WOMAC)	Functional Outcome	1 year
Secondary	Knee Society Score (KSS)	Functional Outcome	1 year
Secondary	EuroQol-5D (EQ-5D)	Quality of Life	1 year
Secondary	Timed Up and Go Test	Function	1 year
Secondary	Adverse events	Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.	1 year
Secondary	Caregiver Assistance Scale	Caregiver Confidence	6 weeks
Secondary	Caregiver Strain Index	Caregiver Strain	6 weeks
Secondary	Patient Satisfaction Questionnaire	Patient satisfaction	2 weeks