Total Knee ArthroplastyNCT04740073
How Muscle and Tendon Properties Contribute to Functional Change Prior to and Following Knee Replacement
An observational study of Total Knee Arthroplasty, run by University of British Columbia at 1 site in Canada.
Trial summary
It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2021to Dec 2024
- Phase
- Observational
- 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 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of 30 patients undergoing unilateral total knee arthroplasty and 30 age- and sex-matched controls not undergoing total knee arthroplasty.
Who may be able to join
- Referred by an orthopedic surgeon to undergo unilateral total knee arthroplasty,
- Age- and sex-matched controls who are not diagnosed with knee or hip osteoarthritis
- Read, speak and understand English
Who cannot join
- Prior replacement of a knee or hip joint
- Cardiometabolic or neurological disease beyond typical age-related decline
- Have had quadriceps tendon surgery
- Have had major and recent injury or surgery to either leg in prior 6 months
- Exclusion from electrical stimulation protocol if they have an implanted electronic device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alterations in Muscle-tendon Mechanics and Contributions to Functional Change Prior to and Following Knee Replacement
It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. This study will use ultrasound and neurophysiological measures to evaluate progressive alterations of tissue to understand functional decline in men and women prior to and following knee replacement surgery. A group of healthy controls not undergoing knee replacement will also be studied to contrast changes in the patient group to normal changes over time. It is hypothesized that from the point of referral to surgery, patients will exhibit reductions in muscle and tendon size (atrophy) and reflex excitability that will be greater in the surgical compared with non-surgical leg, and these changes will precede observable losses in functional measures and strength. Secondly, it is hypothesized that following total knee replacement, muscle and tendon size, reflex activity, strength and functional measures will increase to a level below the pre-surgery values.
Read the detailed description
Osteoarthritis leads to degeneration of the articulating surfaces of the femur and tibia, with the end-stage intervention being replacement of these articulating surfaces using a total knee arthroplasty (TKA) surgical procedure. For patients undergoing TKA, there is a significant decline in functional abilities throughout the waiting period from surgical referral to the surgery date. Following the surgery, there is an improvement in function of these patients, but they do not reach the same functional level as healthy individuals who have not undergone TKA. To objectively measure functional abilities, various tests of strength, mobility and balance can be assessed. To date, no study has been conducted to evaluate how these objective measures of functional ability change throughout the pre-surgery waiting period and how this compares to levels following surgery. To gain a further understanding of the mechanisms behind these changes in function, physiological measures of muscle and tendon can be employed using electrical testing and ultrasound imaging. By evaluating changes in physiology alongside changes in function in TKA patients and healthy controls, we can gain a better understanding of the mechanisms underlying observable changes in function of patients undergoing TKA and how this compares to normal physiological changes in healthy controls.
Patients undergoing total knee replacement will visit the laboratory on 5 separate testing occasions (1, immediately following referral for TKA; 2, midpoint between referral and surgery; 3, 2 weeks prior to surgery; 4, 6 weeks post-surgery; 5, 6 months post-surgery. At each testing session participants will begin by filling out questionnaires related to overall functional ability. They will then perform functional tests of the upper and lower body to gain measures of limb-dependent functional ability. Following functional measures, resting measures of muscle and tendon surrounding the knee and quadriceps muscle group will be obtained using a combination of ultrasound imaging and measurements at the skin surface. Participants will then be equipped will surface electromyography (sEMG) electrodes on the muscles composing the quadriceps and hamstrings muscle groups to measure muscle activity during the subsequent measures. Muscle reflex activity will be assessed through sub-maximal and maximal electrical stimulation of the femoral nerve via carbon stimulation electrodes placed on the skin surface. Participants will then perform three maximal voluntary contractions (MVC) requiring them to extend their leg as hard as possible against the force transducer. Stimulation will be applied prior to, during and following the MVCs to assess the level of muscle activation. From the MVCs, sub-maximal tracking tasks of 5,10,25,50 and 75% MVC will be established. Using the force displayed on a screen in front of the participants, they will be required to produce contractions up to these force levels and maintain the force level for 5 second in order to quantify force steadiness. During these sub-maximal tracking tasks, the ultrasound probe will be placed on the junction between the quadriceps muscle and tendon to record tendon elongation for quantification of tendon mechanical properties.
These procedures will be preformed for the surgical leg of 30 patients undergoing TKA to compare inter-leg differences across time points, and 30 healthy control participants not undergoing TKA who are age-and sex-matched to the patient group will also perform these measures on their non-dominant leg using the same spacing between testing sessions. Measures will be compared between the surgical of patients and the non-dominant leg of healthy controls to evaluate differences over time in the patient group and how this compares to normal changes in a healthy population over the same period of time. This study will try and determine what measures of physiological change prior to surgery best predict optimization of patient function and improvement following surgery.
- Conditions
- Total Knee Arthroplasty
- Keywords
- Knee replacement, function, ultrasound, muscle, tendon, tendon mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Persons undergoing total knee arthroplasty | |
| Controls | Persons not undergoing total knee arthroplasty who are age and sex-matched to the patient group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee extension strength
Maximal isometric knee extensions measured using a dynamometer by having participants push their shin against the dynamometer as hard as they can.
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (4)
Change in force steadiness
Measure of one's ability to control force output of the knee extensors while tracing a target line displayed on the screen. Evaluated using the coefficient of variation of the force where a higher coefficient of variation is a less-steady contraction.
Measured: Through study completion, an average of 1.5 years
Change in Young's modulus
Material property of the tendon consisting of tendon stiffness normalized to the tendon's dimensions (length and cross-sectional area). It is calculated as the slope of the stress-strain relationship where less tendon elongation with applied force leads to a higher Young's Modulus.
Measured: Through study completion, an average of 1.5 years
Change in timed up and go task
Measure of one's ability to rise from a chair, walk a pre-defined distance to a cone, turn around the cone and return to the chair. Time is considered as the time from standing up form the chair until the participant is seated in the chair again. This measure provides an indication of dynamic balance control.
Measured: Through study completion, an average of 1.5 years
Change in balance
Evaluating postural sway from a force platform during bipedal, tandem and single leg stance to determine participants' ability to balance across tasks with increasing difficulties. Participants will be required to maintain the stance as long as they can or until 60 seconds. Sway will be evaluated by analyzing the movement of the centre of pressure.
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Due to COVID-19 and research restrictions put in place by the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Jakobi, University of British Columbia
- Investigators
- Jennifer Jakobi, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740073
- Sponsor's protocol ID
- H18-02179
- Status last verified
- Feb 2021
- First submitted
- 5 Nov 2020
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Muscle-tendon Mechanics and Contributions to Functional Change Prior to and Following Knee Replacement
- ClinicalTrials.gov ID
- NCT04740073
- Acronym / sponsor ID
- H18-02179
- Conditions
- Total Knee Arthroplasty
- Keywords
- Knee replacement, function, ultrasound, muscle, tendon, tendon mechanics
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to COVID-19 and research restrictions put in place by the university
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Feb 2021 (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.
It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. This study will use ultrasound and neurophysiological measures to evaluate progressive alterations of tissue to understand functional decline in men and women prior to and following knee replacement surgery. A group of healthy controls not undergoing knee replacement will also be studied to contrast changes in the patient group to normal changes over time. It is hypothesized that from the point of referral to surgery, patients will exhibit reductions in muscle and tendon size (atrophy) and reflex excitability that will be greater in the surgical compared with non-surgical leg, and these changes will precede observable losses in functional measures and strength. Secondly, it is hypothesized that following total knee replacement, muscle and tendon size, reflex activity, strength and functional measures will increase to a level below the pre-surgery values.
Detailed description
Osteoarthritis leads to degeneration of the articulating surfaces of the femur and tibia, with the end-stage intervention being replacement of these articulating surfaces using a total knee arthroplasty (TKA) surgical procedure. For patients undergoing TKA, there is a significant decline in functional abilities throughout the waiting period from surgical referral to the surgery date. Following the surgery, there is an improvement in function of these patients, but they do not reach the same functional level as healthy individuals who have not undergone TKA. To objectively measure functional abilities, various tests of strength, mobility and balance can be assessed. To date, no study has been conducted to evaluate how these objective measures of functional ability change throughout the pre-surgery waiting period and how this compares to levels following surgery. To gain a further understanding of the mechanisms behind these changes in function, physiological measures of muscle and tendon can be employed using electrical testing and ultrasound imaging. By evaluating changes in physiology alongside changes in function in TKA patients and healthy controls, we can gain a better understanding of the mechanisms underlying observable changes in function of patients undergoing TKA and how this compares to normal physiological changes in healthy controls.
Patients undergoing total knee replacement will visit the laboratory on 5 separate testing occasions (1, immediately following referral for TKA; 2, midpoint between referral and surgery; 3, 2 weeks prior to surgery; 4, 6 weeks post-surgery; 5, 6 months post-surgery. At each testing session participants will begin by filling out questionnaires related to overall functional ability. They will then perform functional tests of the upper and lower body to gain measures of limb-dependent functional ability. Following functional measures, resting measures of muscle and tendon surrounding the knee and quadriceps muscle group will be obtained using a combination of ultrasound imaging and measurements at the skin surface. Participants will then be equipped will surface electromyography (sEMG) electrodes on the muscles composing the quadriceps and hamstrings muscle groups to measure muscle activity during the subsequent measures. Muscle reflex activity will be assessed through sub-maximal and maximal electrical stimulation of the femoral nerve via carbon stimulation electrodes placed on the skin surface. Participants will then perform three maximal voluntary contractions (MVC) requiring them to extend their leg as hard as possible against the force transducer. Stimulation will be applied prior to, during and following the MVCs to assess the level of muscle activation. From the MVCs, sub-maximal tracking tasks of 5,10,25,50 and 75% MVC will be established. Using the force displayed on a screen in front of the participants, they will be required to produce contractions up to these force levels and maintain the force level for 5 second in order to quantify force steadiness. During these sub-maximal tracking tasks, the ultrasound probe will be placed on the junction between the quadriceps muscle and tendon to record tendon elongation for quantification of tendon mechanical properties.
These procedures will be preformed for the surgical leg of 30 patients undergoing TKA to compare inter-leg differences across time points, and 30 healthy control participants not undergoing TKA who are age-and sex-matched to the patient group will also perform these measures on their non-dominant leg using the same spacing between testing sessions. Measures will be compared between the surgical of patients and the non-dominant leg of healthy controls to evaluate differences over time in the patient group and how this compares to normal changes in a healthy population over the same period of time. This study will try and determine what measures of physiological change prior to surgery best predict optimization of patient function and improvement following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Persons undergoing total knee arthroplasty |
| Controls | – | –Persons not undergoing total knee arthroplasty who are age and sex-matched to the patient group. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 30 patients undergoing unilateral total knee arthroplasty and 30 age- and sex-matched controls not undergoing total knee arthroplasty.
Key inclusion criteria (3 listed)
- Referred by an orthopedic surgeon to undergo unilateral total knee arthroplasty,
- Age- and sex-matched controls who are not diagnosed with knee or hip osteoarthritis
- Read, speak and understand English
Key exclusion criteria (5 listed)
- Prior replacement of a knee or hip joint
- Cardiometabolic or neurological disease beyond typical age-related decline
- Have had quadriceps tendon surgery
- Have had major and recent injury or surgery to either leg in prior 6 months
- Exclusion from electrical stimulation protocol if they have an implanted electronic device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in knee extension strength
Time frame: Through study completion, an average of 1.5 years
Maximal isometric knee extensions measured using a dynamometer by having participants push their shin against the dynamometer as hard as they can.
4 secondary outcomes
Change in force steadiness
Time frame: Through study completion, an average of 1.5 years
Change in Young's modulus
Time frame: Through study completion, an average of 1.5 years
Change in timed up and go task
Time frame: Through study completion, an average of 1.5 years
Change in balance
Time frame: Through study completion, an average of 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
Jennifer Jakobi, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty, run by University of British Columbia 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 3 inclusion and 5 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: paused, as of the sponsor's last update on 5 Feb 2021. 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?
Results are not available in the source record.
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?
Change in knee extension strength (time frame: Through study completion, an average of 1.5 years). 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 5 Feb 2021.