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Quadriceps Sparing Versus Standard Total Knee Arthroplasty

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03081663
Collaborator
(none)
83
Enrollment
1
Location
4
Arms
59.7
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Quads-Sparing Approach
  • Procedure: Medial Para-Patellar Approach
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Double (Participant, 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.
Primary Purpose:
Treatment
Official Title:
Cost and Patient Satisfaction After Total Knee Arthroplasty: Standard Medial Para-patellar Versus Quadriceps Sparing Mid-vastus Surgical Approach
Actual Study Start Date :
Jul 11, 2017
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Indirect and Direct Costs of Treatment [1 year]

      ER visits, clinician visits, caregiver lost productivity, tests, etc.

    Secondary Outcome Measures

    1. Pain Numeric Rating Scale [1 year]

      Pain

    2. Short Form - 12 (SF-12) [1 year]

      Quality of Life

    3. Western Ontario McMaster Osteoarthritis Index (WOMAC) [1 year]

      Functional Outcome

    4. Knee Society Score (KSS) [1 year]

      Functional Outcome

    5. EuroQol-5D (EQ-5D) [1 year]

      Quality of Life

    6. Timed Up and Go Test [1 year]

      Function

    7. Adverse events [1 year]

      Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.

    8. Caregiver Assistance Scale [6 weeks]

      Caregiver Confidence

    9. Caregiver Strain Index [6 weeks]

      Caregiver Strain

    10. Patient Satisfaction Questionnaire [2 weeks]

      Patient satisfaction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Centre London Ontario Canada N6A5A5

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Brent A Lanting, MD, London Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Brent Lanting, Orthopaedic Surgeon, Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT03081663
    Other Study ID Numbers:
    • 108949
    First Posted:
    Mar 16, 2017
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Brent Lanting, Orthopaedic Surgeon, Lawson Health Research Institute
    total knee arthroplasty
    quadriceps sparing mid-vastus
    medial para-patellar
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee

    Study Results

    No Results Posted as of Feb 7, 2022