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Quadriceps Sparing Versus Standard Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Knee Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Quads-Sparing Approach
Medial Para-Patellar Approach
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Quads-Sparing Approach with Tourniquet

Medial Para-Patellar with Tourniquet

Quads-Sparing Approach w/o Tourniquet

Medial Para-Patellar w/o Tourniquet

Arm Description

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a 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.

Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no 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.

Outcomes

Primary Outcome Measures

Indirect and Direct Costs of Treatment
ER visits, clinician visits, caregiver lost productivity, tests, etc.

Secondary Outcome Measures

Pain Numeric Rating Scale
Pain
Short Form - 12 (SF-12)
Quality of Life
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Functional Outcome
Knee Society Score (KSS)
Functional Outcome
EuroQol-5D (EQ-5D)
Quality of Life
Timed Up and Go Test
Function
Adverse events
Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Caregiver Assistance Scale
Caregiver Confidence
Caregiver Strain Index
Caregiver Strain
Patient Satisfaction Questionnaire
Patient satisfaction

Full Information

First Posted
March 8, 2017
Last Updated
April 5, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03081663
Brief Title
Quadriceps Sparing Versus Standard Total Knee Arthroplasty
Official Title
Cost and Patient Satisfaction After Total Knee Arthroplasty: Standard Medial Para-patellar Versus Quadriceps Sparing Mid-vastus Surgical Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthroplasty
Keywords
total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quads-Sparing Approach with Tourniquet
Arm Type
Experimental
Arm Description
Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet.
Arm Title
Medial Para-Patellar with Tourniquet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quads-Sparing Approach w/o Tourniquet
Arm Type
Active Comparator
Arm Description
Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet.
Arm Title
Medial Para-Patellar w/o Tourniquet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quads-Sparing Approach
Other Intervention Name(s)
quads-sparing
Intervention Description
Quadriceps-sparing mid-vastus approach for total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Medial Para-Patellar Approach
Other Intervention Name(s)
standard
Intervention Description
Medial para-patellar approach for total knee arthroplasty
Primary Outcome Measure Information:
Title
Indirect and Direct Costs of Treatment
Description
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain Numeric Rating Scale
Description
Pain
Time Frame
1 year
Title
Short Form - 12 (SF-12)
Description
Quality of Life
Time Frame
1 year
Title
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Description
Functional Outcome
Time Frame
1 year
Title
Knee Society Score (KSS)
Description
Functional Outcome
Time Frame
1 year
Title
EuroQol-5D (EQ-5D)
Description
Quality of Life
Time Frame
1 year
Title
Timed Up and Go Test
Description
Function
Time Frame
1 year
Title
Adverse events
Description
Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Time Frame
1 year
Title
Caregiver Assistance Scale
Description
Caregiver Confidence
Time Frame
6 weeks
Title
Caregiver Strain Index
Description
Caregiver Strain
Time Frame
6 weeks
Title
Patient Satisfaction Questionnaire
Description
Patient satisfaction
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A Lanting, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Quadriceps Sparing Versus Standard Total Knee Arthroplasty

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