Arthropathy of KneeNCT05248815
Muscle Strength and Total Knee Replacement
An observational study of Arthropathy of Knee and Osteo Arthritis Knee, run by Vastra Gotaland Region at 3 sites in Sweden.
Trial summary
Purposes: To compare knee extensor muscle strength, physical function and self-reported function before and after total knee replacement with healthy age-matched controls. To describe changes in knee extensor muscle strength up to one year after surgery. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Knee, Osteo Arthritis Knee
- How many people
- 57 participants
- Where
- 3 sitesSweden
- Study dates
- 12 Nov 2021to 1 Dec 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants will be recruited from Alingsås Hospital which is located in the Västra Götaland Region of Sweden.
Who may be able to join
- Scheduled for total knee replacement on the basis of osteoarthritis of the knee
- Expected rehabilitation in a primary care setting
Who cannot join
- Difficulties reading or speaking Swedish
- Revision surgery
- Rehabilitation in other settings than primary care
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Närhälsan Sörhaga Rehabmottagning
Alingsås
Närhälsan Herrljunga Rehabmottagning
Herrljunga
Närhälsan Lerum Rehabmottagning
Lerum
About this study
Official title: Knee Extensor Muscle Strength and Physical Function Before and After Total Knee Replacement
Purposes: To compare knee extensor muscle strength, physical function and self-reported function before and after total knee replacement with healthy age-matched controls. To describe changes in knee extensor muscle strength up to one year after surgery. To study the relationship between changes in knee extensor muscle strength and changes in physical function, self-reported function and physical activity level and the relationship between changes in knee extensor muscle strength and satisfaction.
Methods: A prospective observational study and comparison with controls. 50-55 individuals aged 65 or older, scheduled for total knee arthroplasty will be recruited to the study group. Measurement of study group 0-2 weeks before surgery and 3, 6 and 12 months following surgery. Comparison with 50-55 healthy age-matched controls.
- Conditions
- Arthropathy of Knee, Osteo Arthritis Knee
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 |
|---|---|---|
| Study group | Patients scheduled for total knee replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in knee extensor muscle strength of the affected side from before surgery to one year after surgery
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Measured: Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after surgery
Comparison of knee extensor muscle strength of the affected side before surgery with controls
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Measured: Comparison of data before surgery (0-2 weeks) with data data from the control group
Comparison of knee extensor muscle strength of the affected side one year after surgery with controls
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Measured: Comparison of data one year after surgery with data data from the control group
Comparison of knee extensor muscle strength of the affected side with the unaffected side
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Measured: Before surgery (0-2 weeks). 3, 6 and 12 months after surgery.
Secondary outcomes (5)
Comparison of 30 s chair stand test between study group and control group
30 s chair stand test measures the number of complete stands the test person is able to perform within 30 s.
Measured: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Comparison of Knee injury and Osteoarthritis Outcome Score between study group and control group
Knee Injury and Osteoarthritis Outcome Score is a self-reported outcome questionnaire that measures 5 sub-scales: pain, other symptoms, function in daily living, function in sport and recreation and knee-related quality of life.
Measured: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Comparison of 6-min walk test between study group and control group
Measured: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with changes in 30 s chair stand test, Knee injury and Osteoarthritis Outcome Score, 6-min walk test and physical activity level
Physical activity level will be measured as activity minutes using a questionnaire.
Measured: Before surgery (0-2 weeks) and 12 months after surgery
Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with overall satisfaction one year after surgery
Satisfaction will be measured using a 4-point likert scale.
Measured: Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 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 posted21 Feb 2022
- Study start12 Nov 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anette Larsson, PhD, Principal investigator, Närhälsan Rehabilitering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248815
- Sponsor's protocol ID
- Muscle strength and TKP
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sjostrom P, Nordeman L, Rolfson O, Larsson A. Preoperative factors associated with quadriceps strength 1 year after total knee arthroplasty: a prospective longitudinal study. BMC Musculoskelet Disord. 2026 Oct 21;27(1):914. doi: 10.1186/s12891-026-10657-8.
PubMed 42934625Sjostrom P, Nordeman L, Rolfson O, Larsson A. Knee extensor muscle strength, physical function and patient-reported outcomes the first year after total knee arthroplasty: a prospective longitudinal study. BMC Musculoskelet Disord. 2025 Oct 21;26(1):980. doi: 10.1186/s12891-025-09257-9.
PubMed 41121108
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Extensor Muscle Strength and Physical Function Before and After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05248815
- Acronym / sponsor ID
- Muscle strength and TKP
- Conditions
- Arthropathy of Knee, Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Feb 2022 (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.
Purposes: To compare knee extensor muscle strength, physical function and self-reported function before and after total knee replacement with healthy age-matched controls. To describe changes in knee extensor muscle strength up to one year after surgery. To study the relationship between changes in knee extensor muscle strength and changes in physical function, self-reported function and physical activity level and the relationship between changes in knee extensor muscle strength and satisfaction.
Methods: A prospective observational study and comparison with controls. 50-55 individuals aged 65 or older, scheduled for total knee arthroplasty will be recruited to the study group. Measurement of study group 0-2 weeks before surgery and 3, 6 and 12 months following surgery. Comparison with 50-55 healthy age-matched controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients scheduled for total knee replacement. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants will be recruited from Alingsås Hospital which is located in the Västra Götaland Region of Sweden.
Key inclusion criteria (2 listed)
- Scheduled for total knee replacement on the basis of osteoarthritis of the knee
- Expected rehabilitation in a primary care setting
Key exclusion criteria (3 listed)
- Difficulties reading or speaking Swedish
- Revision surgery
- Rehabilitation in other settings than primary care
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
Changes in knee extensor muscle strength of the affected side from before surgery to one year after surgery
Time frame: Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after surgery
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Comparison of knee extensor muscle strength of the affected side before surgery with controls
Time frame: Comparison of data before surgery (0-2 weeks) with data data from the control group
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Comparison of knee extensor muscle strength of the affected side one year after surgery with controls
Time frame: Comparison of data one year after surgery with data data from the control group
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
Comparison of knee extensor muscle strength of the affected side with the unaffected side
Time frame: Before surgery (0-2 weeks). 3, 6 and 12 months after surgery.
Maximum voluntary isometric contraction measured using the "make" method with hand-held dynamometry fixated in a knee extension strength training apparatus. Force measurement in Newtons.
5 secondary outcomes
Comparison of 30 s chair stand test between study group and control group
Time frame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Comparison of Knee injury and Osteoarthritis Outcome Score between study group and control group
Time frame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Comparison of 6-min walk test between study group and control group
Time frame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with changes in 30 s chair stand test, Knee injury and Osteoarthritis Outcome Score, 6-min walk test and physical activity level
Time frame: Before surgery (0-2 weeks) and 12 months after surgery
Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with overall satisfaction one year after surgery
Time frame: Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 12 months after surgery
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 25 May 2025.
- Derived from this study: PubMed 42934625Sjostrom P, Nordeman L, Rolfson O, Larsson A. Preoperative factors associated with quadriceps strength 1 year after total knee arthroplasty: a prospective longitudinal study. BMC Musculoskelet Disord. 2026 Oct 21;27(1):914. doi: 10.1186/s12891-026-10657-8.
- Derived from this study: PubMed 41121108Sjostrom P, Nordeman L, Rolfson O, Larsson A. Knee extensor muscle strength, physical function and patient-reported outcomes the first year after total knee arthroplasty: a prospective longitudinal study. BMC Musculoskelet Disord. 2025 Oct 21;26(1):980. doi: 10.1186/s12891-025-09257-9.
- 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.
Anette Larsson, PhD principal investigator
Närhälsan Rehabilitering
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Knee and Osteo Arthritis Knee, run by Vastra Gotaland Region at 3 sites in Sweden.
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: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Changes in knee extensor muscle strength of the affected side from before surgery to one year after surgery (time frame: Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after 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?
On the ClinicalTrials.gov record for NCT05248815, which also lists 2 linked publications.
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 25 May 2025.