Knee OsteoarthritisNCT03081663
Quadriceps Sparing Versus Standard Total Knee Arthroplasty
A study testing Quads-Sparing Approach and Medial Para-Patellar Approach in people with Knee Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthroplasty
- What is being tested?
- Quads-Sparing Approach and Medial Para-Patellar Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2017to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Being tested
- Quads-Sparing Approach, Medial Para-Patellar Approach
- Keywords
- total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quads-Sparing ApproachProcedure or surgery
Also called quads-sparing
Quadriceps-sparing mid-vastus approach for total knee arthroplasty
Medial Para-Patellar ApproachProcedure or surgery
Also called standard
Medial para-patellar approach for total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Quads-Sparing Approach with Tourniquet | Experimental | Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet. Receives: Procedure: Quads-Sparing Approach |
| Medial Para-Patellar with Tourniquet | Active comparator | 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. Receives: Procedure: Medial Para-Patellar Approach |
| Quads-Sparing Approach w/o Tourniquet | Active comparator | Participants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet. Receives: Procedure: Quads-Sparing Approach |
| Medial Para-Patellar w/o Tourniquet | Active comparator | 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. Receives: Procedure: Medial Para-Patellar Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indirect and Direct Costs of Treatment
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Measured: 1 year
Secondary outcomes (10)
Pain Numeric Rating Scale
Pain
Measured: 1 year
Short Form - 12 (SF-12)
Quality of Life
Measured: 1 year
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Functional Outcome
Measured: 1 year
Knee Society Score (KSS)
Functional Outcome
Measured: 1 year
EuroQol-5D (EQ-5D)
Quality of Life
Measured: 1 year
Timed Up and Go Test
Function
Measured: 1 year
Adverse events
Falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Measured: 1 year
Caregiver Assistance Scale
Caregiver Confidence
Measured: 6 weeks
Caregiver Strain Index
Caregiver Strain
Measured: 6 weeks
Patient Satisfaction Questionnaire
Patient satisfaction
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start11 Jul 2017
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent Lanting, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Brent A Lanting, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081663
- Sponsor's protocol ID
- 108949
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2017
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost and Patient Satisfaction After Total Knee Arthroplasty: Standard Medial Para-patellar Versus Quadriceps Sparing Mid-vastus Surgical Approach
- ClinicalTrials.gov ID
- NCT03081663
- Acronym / sponsor ID
- 108949
- Conditions
- Knee Osteoarthritis, Knee Arthroplasty
- Keywords
- total knee arthroplasty, quadriceps sparing mid-vastus, medial para-patellar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quads-Sparing Approach with Tourniquet | Experimental | Procedure: Quads-Sparing ApproachParticipants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and a tourniquet. |
| Medial Para-Patellar with Tourniquet | Active comparator | Procedure: Medial Para-Patellar ApproachParticipants 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. |
| Quads-Sparing Approach w/o Tourniquet | Active comparator | Procedure: Quads-Sparing ApproachParticipants will have a navigated total knee arthroplasty with a quadriceps-sparing mid-vastus approach and no tourniquet. |
| Medial Para-Patellar w/o Tourniquet | Active comparator | Procedure: Medial Para-Patellar ApproachParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quads-Sparing ApproachAlso: quads-sparingQuadriceps-sparing mid-vastus approach for total knee arthroplasty | Procedure or surgery | Quads-Sparing Approach w/o Tourniquet, Quads-Sparing Approach with Tourniquet |
| Medial Para-Patellar ApproachAlso: standardMedial para-patellar approach for total knee arthroplasty | Procedure or surgery | Medial Para-Patellar w/o Tourniquet, Medial Para-Patellar with Tourniquet |
Primary outcome
Indirect and Direct Costs of Treatment
Time frame: 1 year
ER visits, clinician visits, caregiver lost productivity, tests, etc.
10 secondary outcomes
Pain Numeric Rating Scale
Time frame: 1 year
Short Form - 12 (SF-12)
Time frame: 1 year
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Time frame: 1 year
Knee Society Score (KSS)
Time frame: 1 year
EuroQol-5D (EQ-5D)
Time frame: 1 year
Timed Up and Go Test
Time frame: 1 year
Adverse events
Time frame: 1 year
Caregiver Assistance Scale
Time frame: 6 weeks
Caregiver Strain Index
Time frame: 6 weeks
Patient Satisfaction Questionnaire
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A Lanting, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quads-Sparing Approach and Medial Para-Patellar Approach in people with Knee Osteoarthritis and Knee Arthroplasty, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indirect and Direct Costs of Treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.