Postural BalanceNCT04681404
Balance After Knee Arthroplasty
A study testing Knee Arthroplasty in people with Postural Balance and Knee Arthroplasty, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Postural Balance, Knee Arthroplasty, Quality of Life
- What is being tested?
- Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 11 Jan 2021to Dec 2023
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary gonarthrosis
- planned TKA or UKA
- adequate cognitive and lingual competence
- informed consent
Who cannot join
- TKA or UKA revision
- Surgery after trauma
- Rheumatic disease
- Neurologic disease
- previous arthroplasty of the lower extremity (<9 months)
- cardiovascular disease
- restricted weight bearing of the lower extremity after surgery
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, 4020
Christian Mittermaier, M.D., christian.mittermaier@kepleruniklinikum.at
About this study
Official title: Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.
- Conditions
- Postural Balance, Knee Arthroplasty, Quality of Life
- Being tested
- Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee ArthroplastyProcedure or surgery
Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty (TKA) | Active comparator | Patients intended to undergo surgery for total knee arthroplasty Receives: Procedure: Knee Arthroplasty |
| Unicompartmental Knee Arthroplasty (UKA) | Active comparator | Patients intended to undergo surgery for unicompartmental knee arthroplasty Receives: Procedure: Knee Arthroplasty |
| Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure track (COPT)
Posturographic Parameter
Measured: Before surgery
Center of pressure track (COPT)
Posturographic Parameter
Measured: Day 3-7 after surgery
Center of pressure track (COPT)
Posturographic Parameter
Measured: 3 months after surgery
Center of pressure track (COPT)
Posturographic Parameter
Measured: 1 year after surgery
Secondary outcomes (18)
Functional reach test
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Timed up and go - test
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Knee Injury and Osteoarthritis Outcome Score
Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
EQ-5D - Score
Scale: Points, Minimum: 1, Maximum: <0, higher score means better outcome
Measured: Before surgery; 1 year after surgery
10 m Walking test
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
WOMAC Score
Scale: Points, Minimum: 0, Maximum: 240, higher score means worse outcome
Measured: Before surgery; 1 year after surgery, higher score means better outcome
Forgotten Joint Score
Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome
Measured: Before surgery; 1 year after surgery
Oxford Knee Score
Scale: Points, Minimum: 12, Maximum: 60, higher score means worse outcome
Measured: Before surgery; 1 year after surgery
Knee Society Score
Scale: Points, Minimum: 0, Maximum: 100, higher score means better outcome
Measured: Before surgery; 1 year after surgery
The University of California at Los Angeles Activity Score
Scale: Points, Minimum: 1, Maximum: 10, higher score means better outcome
Measured: Before surgery; 1 year after surgery
Area of Sway
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Frequency of Sway
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Harmony Index
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Stability energy
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Movement control
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Feedback (visual, somatosensoric, vestibular)
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Weight Distribution Index
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Fulfillment of Tests
Posturographic Parameter
Measured: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start11 Jan 2021
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Kepler University Hospital
- Responsible party
- Principal investigator, Christian Mittermaier, Johannes Kepler University of Linz
- Investigators
- Christian Mittermaier, Dr, Principal investigator, Kepler University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681404
- Sponsor's protocol ID
- PMR_Knee TKA 001
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
- ClinicalTrials.gov ID
- NCT04681404
- Acronym / sponsor ID
- PMR_Knee TKA 001
- Conditions
- Postural Balance, Knee Arthroplasty, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Kepler University Hospital
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Dec 2020 (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.
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty (TKA) | Active comparator | Procedure: Knee ArthroplastyPatients intended to undergo surgery for total knee arthroplasty |
| Unicompartmental Knee Arthroplasty (UKA) | Active comparator | Procedure: Knee ArthroplastyPatients intended to undergo surgery for unicompartmental knee arthroplasty |
| Healthy Control | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary gonarthrosis
- planned TKA or UKA
- adequate cognitive and lingual competence
- informed consent
Key exclusion criteria (7 listed)
- TKA or UKA revision
- Surgery after trauma
- Rheumatic disease
- Neurologic disease
- previous arthroplasty of the lower extremity (<9 months)
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 |
|---|---|---|
| Knee ArthroplastyComparison of TKA, UKA and healthy controls in relation to balance, function and QOL | Procedure or surgery | Total Knee Arthroplasty (TKA), Unicompartmental Knee Arthroplasty (UKA) |
Primary outcome
Center of pressure track (COPT)
Time frame: Before surgery
Posturographic Parameter
Center of pressure track (COPT)
Time frame: Day 3-7 after surgery
Posturographic Parameter
Center of pressure track (COPT)
Time frame: 3 months after surgery
Posturographic Parameter
Center of pressure track (COPT)
Time frame: 1 year after surgery
Posturographic Parameter
18 secondary outcomes
Functional reach test
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Timed up and go - test
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Knee Injury and Osteoarthritis Outcome Score
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
EQ-5D - Score
Time frame: Before surgery; 1 year after surgery
10 m Walking test
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
WOMAC Score
Time frame: Before surgery; 1 year after surgery, higher score means better outcome
Forgotten Joint Score
Time frame: Before surgery; 1 year after surgery
Oxford Knee Score
Time frame: Before surgery; 1 year after surgery
Knee Society Score
Time frame: Before surgery; 1 year after surgery
The University of California at Los Angeles Activity Score
Time frame: Before surgery; 1 year after surgery
Area of Sway
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Frequency of Sway
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Harmony Index
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Stability energy
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Movement control
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Feedback (visual, somatosensoric, vestibular)
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Weight Distribution Index
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Fulfillment of Tests
Time frame: Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Christian Mittermaier, Dr principal investigator
Kepler University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Arthroplasty in people with Postural Balance and Knee Arthroplasty, run by Johannes Kepler University of Linz at 1 site in Austria.
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 4 inclusion and 7 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 30 Mar 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 Austria. 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?
Contact Christian Mittermaier, Dr (+43 5 7680 83 ext. 73779, christian.mittermaier@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure track (COPT) (time frame: Before surgery). The study lists 4 primary outcomes in all. 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 30 Mar 2023.