Total Knee ReplacementNCT03997565
Motor Performance Modulation After Total Knee Replacement
An observational study of Total Knee Replacement, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Functional recovery after total knee replacement (TKR) is characterized by an incomplete muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the functional level. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- TKR
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 1 Sep 2019
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients: subjects undergoing total knee replacement intervention because of primary gonarthrosis. Healty subjects: people with no known significant health problems who are recruited to participate as controls for a patient Group.
Who may be able to join
- Age between 40 and 80 years
- TKR because of primary gonarthrosis
- Flexion ≥ 90° and complete knee extension
- Able to perform a Sit to Stand from a 46 cm high chair, without upper limb use
- Able to walk at least 50 meters without walking aids
Who cannot join
- TKR because of traumatic event
- Patients undergone to tibial or femoral osteotomy
- Partial or Total TKR revision
- Cognitive and psychiatric impairments
- Presence of neurological, internist or musculoskeletal system pathologies that may affect functional or motor recovery
- Healthy subjects will have to comply with all the eligibility criteria just mentioned except for the inclusion criterion: Intervention of TKR following primary gonarthrosis
Trial locations and contacts
1 site in 1 country.
About this study
Functional recovery after total knee replacement (TKR) is characterized by an incomplete muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the functional level. These deficits could be related to alteration of sensory feedback, and could influence the ability to modulate patients' motor performance.
To date, there are not studies investigatin the ability to modulate the motor performance in patients with TKR compared to healthy age-matched subjects.
Read more
In this study 20 patients with TKR and 20 healthy will be included . Inclusion criteria are: age between 40 and 80 , TKR for primary knee osteoarthritis, knee flexion ≥ 90° and complete knee extension, ability to perform a sit to stand on a 46 cm high chair and to walk for at least 50 meters without aids. Exclusion criteria: patients undergoing TKR after traumas, previous tibial or femoral osteotomy, partial or complete revision surgery. subjects with psychiatric and/or cognitive impairments, or with neurological, musculoskeletal or other disorders that could influence motor or functional recovery will be also exluded.
The aim of the study is to investigate the ability in motor performance modulation in patients after TKR compared to healthy age-mtched subjects.
Primary endpoint is to investigate this ability during a leg extension performed in open kinetic chain. This ability will be also evaluated during a Sit To Stand and during walking (with 10 Meters Walking Test). Secondary endpoint is to investigate pain, rate of perceived exertion and perceived load symmetry during the three tests. In both healthy and TKR groups these outcomes will be detected two times. In particular, in TKR group, patients will be tested the day before surgery and 5 days after surgery.
This study is aimed at conducting a survey in healthy subjects and in a population of subjects undergoing TKR . Participants will undergo an acquisition similar to others already described in the literature and without adverse events. Tests will last about 60 minutes and during them, will be used the equipment of Motion Analysis Lab of "Humanitas Research Hospital".
- Conditions
- Total Knee Replacement
- Being tested
- TKR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKRProcedure or surgery
No intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects.
| Study group | Role | What they receive |
|---|---|---|
| Patients TKR | Not described Receives: Procedure: TKR | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Torque (PT) in N*m
Force reproduction error between the PT-target and the PT-observed during knee extension with an isokinetic dynamometer (Ω = 60 °/s)
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Secondary outcomes (5)
Change in Overshoot (OS) in N
The error between OS-target and OS-observed during Sit-to-Stand using two force platforms.
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in Walking speed (WS) in m/s
Error between "target speed" and "observed speed" during 10 meters walking test
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in pain using Visual Analogue Scale (VAS)
Pain will be assessed with Visual Analogue Scale (VAS 0-10) ranging from 0 (absence of pain) to 10 (maximum pain)
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in exertion using Modified Borg Scale
Perceived exertion will be assessed with Modified Borg Scale (0-10), ranging from 0 (no exertion) to 10 (maximum exertion)
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in perceived body weight distribution using Visual Analogue Scale (VAS)
Perceived symmetry of load will be assessed with Visual Analogue Scale (VAS), ranging from -10 (body weight on left limb) to 10 (body weight on right limb). A value of 0 denotes perfect symmetry.
Measured: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997565
- Sponsor's protocol ID
- 749
- Status last verified
- Sep 2021
- First submitted
- 10 Jun 2019
- Last updated
- 16 Sep 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Performance Modulation After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03997565
- Acronym / sponsor ID
- 749
- Conditions
- Total Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 25 Jun 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.
Functional recovery after total knee replacement (TKR) is characterized by an incomplete muscle strength due to arthrogenic muscle inhibition (AMI) and tendency to estimate the functional level. These deficits could be related to alteration of sensory feedback, and could influence the ability to modulate patients' motor performance.
To date, there are not studies investigatin the ability to modulate the motor performance in patients with TKR compared to healthy age-matched subjects.
In this study 20 patients with TKR and 20 healthy will be included . Inclusion criteria are: age between 40 and 80 , TKR for primary knee osteoarthritis, knee flexion ≥ 90° and complete knee extension, ability to perform a sit to stand on a 46 cm high chair and to walk for at least 50 meters without aids. Exclusion criteria: patients undergoing TKR after traumas, previous tibial or femoral osteotomy, partial or complete revision surgery. subjects with psychiatric and/or cognitive impairments, or with neurological, musculoskeletal or other disorders that could influence motor or functional recovery will be also exluded.
The aim of the study is to investigate the ability in motor performance modulation in patients after TKR compared to healthy age-mtched subjects.
Primary endpoint is to investigate this ability during a leg extension performed in open kinetic chain. This ability will be also evaluated during a Sit To Stand and during walking (with 10 Meters Walking Test). Secondary endpoint is to investigate pain, rate of perceived exertion and perceived load symmetry during the three tests. In both healthy and TKR groups these outcomes will be detected two times. In particular, in TKR group, patients will be tested the day before surgery and 5 days after surgery.
This study is aimed at conducting a survey in healthy subjects and in a population of subjects undergoing TKR . Participants will undergo an acquisition similar to others already described in the literature and without adverse events. Tests will last about 60 minutes and during them, will be used the equipment of Motion Analysis Lab of "Humanitas Research Hospital".
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients TKR | – | Procedure: TKR |
| Healthy subjects | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients: subjects undergoing total knee replacement intervention because of primary gonarthrosis. Healty subjects: people with no known significant health problems who are recruited to participate as controls for a patient Group.
Key inclusion criteria (5 listed)
- Age between 40 and 80 years
- TKR because of primary gonarthrosis
- Flexion ≥ 90° and complete knee extension
- Able to perform a Sit to Stand from a 46 cm high chair, without upper limb use
- Able to walk at least 50 meters without walking aids
Key exclusion criteria (6 listed)
- TKR because of traumatic event
- Patients undergone to tibial or femoral osteotomy
- Partial or Total TKR revision
- Cognitive and psychiatric impairments
- Presence of neurological, internist or musculoskeletal system pathologies that may affect functional or motor recovery
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 |
|---|---|---|
| TKRNo intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects. | Procedure or surgery | Patients TKR |
Primary outcome
Change in Peak Torque (PT) in N*m
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Force reproduction error between the PT-target and the PT-observed during knee extension with an isokinetic dynamometer (Ω = 60 °/s)
5 secondary outcomes
Change in Overshoot (OS) in N
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in Walking speed (WS) in m/s
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in pain using Visual Analogue Scale (VAS)
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in exertion using Modified Borg Scale
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
Change in perceived body weight distribution using Visual Analogue Scale (VAS)
Time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)
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 16 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Replacement, 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 5 inclusion and 6 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 16 Sep 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 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?
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?
Change in Peak Torque (PT) in N*m (time frame: Patients will be evaluated the day before (T0) and the fifth day after surgery (T1), whereas healthy subjects will perform two evaluations, the first one at T0 and the second one 5 days after (T1)). 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 16 Sep 2021.