Knee Arthroplasty, TotalLOVKNEENCT06847113
Maximal and Self-selected Walkingspeed After Knee Arthroplasty - a Prospective Cohort Study
An observational study of Knee Arthroplasty, Total, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Physical function
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- 20 Nov 2024to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Persons with knee osteoarthritis scheduled for knee arthroplasty at Lovisenberg Diaconal Hospital who meet the eligibility criteria
Who may be able to join
None listed.
Who cannot join
- Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Lovisenberg Diaconal Hospital
Oslo
Brita Stanghelle, PhD, +47 97514751, brita.stanghelle@lds.no
About this study
Official title: MAXIMAL and SELF-SELECTED WALKING SPEED AFTER KNEE ARTHROPLASTY
The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical functionOther
Observe walking speed, both maximal and self-selected, over a 12-months period after knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Persons scheduled for knee arthroplasty | Age 55 or over, scheduled for primary uni or total knee arthroplasty, able to walk indepentdently with or without walkingaids, living in the eastern part of Norway within 1-2 hours commute from Oslo, able understand Norwegian for instructions and filling out forms, Receives: Other: Physical function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn
Walking speed will be measured by 10 meter self-selected and maximal walking speed, respectively. Participant will perform two repetitions of self-selected walking speed, followed by two repetitions of maximal walking speed. Mean, measured by meters per seconds, will be calculated onboth of the two different walking speeds.
Measured: Baseline, 3 months and 12 months after surgery
Secondary outcomes (4)
Sit-to-stand
Lower extremity strength will be measured by 30 sec sit to stand. Number of standing up in 30 seconds will be counted and recorded
Measured: Baseline, 3 months and 12 months after surgery
One legged stance
Balance will be measured by one legged stance. The participant will perform the test by standing on one leg and the other in 90 degrees flexion of the hip and knee, hands on hips. The test will be performed twice, with the non-affected leg to be tested first. The best of the two scores for each leg will be recorded.
Measured: Baseline, 3 months and 12 months after surgery
Knee specific function and pain
Pain and function in the knee will be measured by the patient reported form KOOS which includes 42 questions evaluating pain and function in different activities in daily life the last week.
Measured: Baseline and 12 months
EQ5D- Health-related quality of life
Measures self-reported health-related quality of life.
Measured: Baseline and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start20 Nov 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847113
- Sponsor's protocol ID
- 764176
- Acronym
- LOVKNEE
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAXIMAL and SELF-SELECTED WALKING SPEED AFTER KNEE ARTHROPLASTY
- ClinicalTrials.gov ID
- NCT06847113
- Acronym / sponsor ID
- LOVKNEE / 764176
- Conditions
- Knee Arthroplasty, Total
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Feb 2025 (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.
The purpose of this prospective study is to explore whether maximal and self-selected walking speed in individuals with knee arthroplasty is a useful and applicable clinical measure that can provide new insights into physical function after prosthetic surgery. We will examine the progression of walking speed and other measures of physical function, and investigate if walking speed can predict postoperative function. Individuals over 55 years, scheduled for knee arthroplasty will be invited to participate. Standardized functional tests such as walking speed, sit to stand and one legged stance along with patient reported outcomes will be assessed preoperatively, three months and 12 months after surgery. The study may provide useful knowledge that can be aplied clinically in the assessment and follow-up of this patient group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons scheduled for knee arthroplasty | – | Other: Physical functionAge 55 or over, scheduled for primary uni or total knee arthroplasty, able to walk indepentdently with or without walkingaids, living in the eastern part of Norway within 1-2 hours commute from Oslo, able understand Norwegian for instructions and filling out forms, |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with knee osteoarthritis scheduled for knee arthroplasty at Lovisenberg Diaconal Hospital who meet the eligibility criteria
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Other reasons than osteoarthritis for knee arthroplasty, revision due to infection or failure, arthroplasty in the same or other limb during the 12 months time period, severe neurological or ohter types of disease that affects walking (e.g MS; parkinsonism, hemiplegiea)
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 |
|---|---|---|
| Physical functionObserve walking speed, both maximal and self-selected, over a 12-months period after knee arthroplasty | Other | Persons scheduled for knee arthroplasty |
Primary outcome
Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn
Time frame: Baseline, 3 months and 12 months after surgery
Walking speed will be measured by 10 meter self-selected and maximal walking speed, respectively. Participant will perform two repetitions of self-selected walking speed, followed by two repetitions of maximal walking speed. Mean, measured by meters per seconds, will be calculated onboth of the two different walking speeds.
4 secondary outcomes
Sit-to-stand
Time frame: Baseline, 3 months and 12 months after surgery
One legged stance
Time frame: Baseline, 3 months and 12 months after surgery
Knee specific function and pain
Time frame: Baseline and 12 months
EQ5D- Health-related quality of life
Time frame: Baseline and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- 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.
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 Knee Arthroplasty, Total, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 0 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brita Stanghelle, PhD (+47 97514751, brita.stanghelle@oslomet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 3 and 12 months in means in maximal and self-selected walking speed walikgn (time frame: Baseline, 3 months and 12 months after surgery). 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 26 Feb 2025.