Arthroplasty, Knee ReplacementNCT04152538
Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects
An observational study of Arthroplasty, Knee Replacement and Musculoskeletal Disorder, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle.The aim of the study is to investigate differences in quadriceps neuromuscular activity in the acute phase after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Knee Replacement, Musculoskeletal Disorder
- What is being tested?
- not intervention but investigation
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2019to 28 Feb 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample and hospitalized patients
Who may be able to join
- age: over 18 years.
- subjects eligible for TKA.
Who cannot join
- QAB (quadriceps activation battery) < 6 the day before the operation
- neurological or musculoskeletal diseases (different from the causes that which led the patient to the TKA), which may interfere with the quadriceps muscle activation or with motor performance of the subject.
- Uncooperative subjects.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Roberto Gatti
Rozzano, Milan, 20089
Roberto Gatti, Prof, 0282245610, roberto.gatti@hunimed.eu
Roberto Gatti, Prof
About this study
During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle.The aim of the study is to investigate differences in quadriceps neuromuscular activity in the acute phase after surgery.
Read the detailed description
During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle. The current phenomenon depends on a complex mechanism called Arthrogenic Muscle Inhibition (AMI). AMI has been studied only in sub-acute and chronic phase after TKA due to the invasive procedures employed in order to evaluate it; However, clinical observation and experimental studies suggest presence of this phenomenon also in the first postoperative days. The aim of the study is to investigate differences in quadriceps neuromuscular activity, in acute phase.
The study is a prospective observational study.15 healthy subjects and 15 patients scheduled for TKA will be recruited. Patients will be asked to perform three isokinetic taks in the same standardized biomechanical context in order to evaluate changes in quadriceps neuromuscular activity after surgery as primary outcome. Secondly, correlation between primary aim and pain perceived by the patient will be investigated. Moreover, patient's functional ability will be assessed using the Timed Up and Go Test (TUG). Data will be recorded the day before TKA, at one and three days after surgery.
At the end of data acquisition, normality and homogeneity of demographic variables will be assessed. Differences in the outcome measures will be investigated with the t student test (or with the related non-parametric tests) and by means of the mixed models repeated measures ANOVA test. Linear regression will be applied to evaluate any correlation between outcomes.
- Being tested
- not intervention but investigation
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not intervention but investigationOther
possible differences in quadriceps muscular activity
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | Healthy subjects matched with TKA patients Receives: Other: not intervention but investigation | |
| TKA patients | age greater than 18 years old and a recent TKA. Receives: Other: not intervention but investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps muscle activity
Surface EMG, RMS peak (mV)
Measured: day before surgery, first postoperative day, third postoperative day for TKA group
Secondary outcomes (2)
Change in pain perception
Numeric Rating Scale (NRS) 0-10. A value of 0 represents absence of pain, whereas a value of 10 represents maximum pain
Measured: day before surgery, first postoperative day, third postoperative day for TKA group
Change in walking ability
Timed Up and Go (TUG) evaluated in seconds,
Measured: day before surgery, thurd postoperative day for TKA group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Jul 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152538
- Sponsor's protocol ID
- CLF19/03
- Status last verified
- Nov 2019
- First submitted
- 30 Jul 2019
- Last updated
- 5 Nov 2019
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects
- ClinicalTrials.gov ID
- NCT04152538
- Acronym / sponsor ID
- CLF19/03
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 5 Nov 2019 (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.
During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle.The aim of the study is to investigate differences in quadriceps neuromuscular activity in the acute phase after surgery.
Detailed description
During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle. The current phenomenon depends on a complex mechanism called Arthrogenic Muscle Inhibition (AMI). AMI has been studied only in sub-acute and chronic phase after TKA due to the invasive procedures employed in order to evaluate it; However, clinical observation and experimental studies suggest presence of this phenomenon also in the first postoperative days. The aim of the study is to investigate differences in quadriceps neuromuscular activity, in acute phase.
The study is a prospective observational study.15 healthy subjects and 15 patients scheduled for TKA will be recruited. Patients will be asked to perform three isokinetic taks in the same standardized biomechanical context in order to evaluate changes in quadriceps neuromuscular activity after surgery as primary outcome. Secondly, correlation between primary aim and pain perceived by the patient will be investigated. Moreover, patient's functional ability will be assessed using the Timed Up and Go Test (TUG). Data will be recorded the day before TKA, at one and three days after surgery.
At the end of data acquisition, normality and homogeneity of demographic variables will be assessed. Differences in the outcome measures will be investigated with the t student test (or with the related non-parametric tests) and by means of the mixed models repeated measures ANOVA test. Linear regression will be applied to evaluate any correlation between outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Other: not intervention but investigationHealthy subjects matched with TKA patients |
| TKA patients | – | Other: not intervention but investigationage greater than 18 years old and a recent TKA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample and hospitalized patients
Key inclusion criteria (2 listed)
- age: over 18 years.
- subjects eligible for TKA.
Key exclusion criteria (3 listed)
- QAB (quadriceps activation battery) < 6 the day before the operation
- neurological or musculoskeletal diseases (different from the causes that which led the patient to the TKA), which may interfere with the quadriceps muscle activation or with motor performance of the subject.
- Uncooperative subjects.
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 |
|---|---|---|
| not intervention but investigationpossible differences in quadriceps muscular activity | Other | TKA patients, healthy subjects |
Primary outcome
Change in quadriceps muscle activity
Time frame: day before surgery, first postoperative day, third postoperative day for TKA group
Surface EMG, RMS peak (mV)
2 secondary outcomes
Change in pain perception
Time frame: day before surgery, first postoperative day, third postoperative day for TKA group
Change in walking ability
Time frame: day before surgery, thurd postoperative day for TKA group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- 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.
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 Arthroplasty, Knee Replacement and Musculoskeletal Disorder, run by Istituto Clinico Humanitas at 1 site in Italy.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quadriceps muscle activity (time frame: day before surgery, first postoperative day, third postoperative day for TKA group). 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 Nov 2019.