- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05248815
Muscle Strength and Total Knee Replacement
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alingsås, Sweden
- Närhälsan Sörhaga Rehabmottagning
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Herrljunga, Sweden
- Närhälsan Herrljunga Rehabmottagning
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Lerum, Sweden
- Närhälsan Lerum Rehabmottagning
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Scheduled for total knee replacement on the basis of osteoarthritis of the knee
- Expected rehabilitation in a primary care setting
Exclusion Criteria:
- Difficulties reading or speaking Swedish
- Revision surgery
- Rehabilitation in other settings than primary care
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study group
Patients scheduled for total knee replacement.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after surgery
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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
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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.
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Comparison of data before surgery (0-2 weeks) with data data from the control group
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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
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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.
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Comparison of data one year after surgery with data data from the control group
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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.
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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.
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Before surgery (0-2 weeks). 3, 6 and 12 months after surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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30 s chair stand test measures the number of complete stands the test person is able to perform within 30 s.
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Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
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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
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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.
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Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
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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
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Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
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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
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Physical activity level will be measured as activity minutes using a questionnaire.
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Before surgery (0-2 weeks) and 12 months after surgery
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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
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Satisfaction will be measured using a 4-point likert scale.
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Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 12 months after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anette Larsson, PhD, Närhälsan Rehabilitering
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Muscle strength and TKP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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