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Completed

NCT Number: NCT03081663

Quadriceps Sparing Versus Standard Total Knee Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quads-Sparing Approach

Procedure

Quadriceps-sparing mid-vastus approach for total knee arthroplasty

Other names: quads-sparing

Medial Para-Patellar Approach

Procedure

Medial para-patellar approach for total knee arthroplasty

Other names: standard

Primary outcomes

  1. Indirect and Direct Costs of Treatment

    Time frame: 1 year

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

Secondary outcomes

  1. Pain Numeric Rating Scale

    Time frame: 1 year

    Pain

  2. Short Form - 12 (SF-12)

    Time frame: 1 year

    Quality of Life

  3. Western Ontario McMaster Osteoarthritis Index (WOMAC)

    Time frame: 1 year

    Functional Outcome

  4. Knee Society Score (KSS)

    Time frame: 1 year

    Functional Outcome

  5. EuroQol-5D (EQ-5D)

    Time frame: 1 year

    Quality of Life

  6. Timed Up and Go Test

    Time frame: 1 year

    Function

  7. Adverse events

    Time frame: 1 year

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

  8. Caregiver Assistance Scale

    Time frame: 6 weeks

    Caregiver Confidence

  9. Caregiver Strain Index

    Time frame: 6 weeks

    Caregiver Strain

  10. Patient Satisfaction Questionnaire

    Time frame: 2 weeks

    Patient satisfaction

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2017
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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