Clinical trial NCT05248815: Muscle Strength and Total Knee Replacement
Official title: Knee Extensor Muscle Strength and Physical Function Before and After Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee
Osteo Arthritis Knee
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-02-21
Enrollment: 57
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from Alingsås Hospital which is located in the Västra Götaland Region of Sweden.

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in knee extensor muscle strength of the affected side from before surgery to one year after surgery
timeFrame: Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after surgery
measure: Comparison of knee extensor muscle strength of the affected side before surgery with controls
timeFrame: Comparison of data before surgery (0-2 weeks) with data data from the control group
measure: Comparison of knee extensor muscle strength of the affected side one year after surgery with controls
timeFrame: Comparison of data one year after surgery with data data from the control group
measure: Comparison of knee extensor muscle strength of the affected side with the unaffected side
timeFrame: Before surgery (0-2 weeks). 3, 6 and 12 months after surgery.
Secondary outcomes:
measure: Comparison of 30 s chair stand test between study group and control group
timeFrame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
measure: Comparison of Knee injury and Osteoarthritis Outcome Score between study group and control group
timeFrame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
measure: Comparison of 6-min walk test between study group and control group
timeFrame: Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
measure: 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
timeFrame: Before surgery (0-2 weeks) and 12 months after surgery
measure: Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with overall satisfaction one year after surgery
timeFrame: Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 12 months after surgery
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Närhälsan Sörhaga Rehabmottagning
city: Herrljunga
country: Sweden
facility: Närhälsan Herrljunga Rehabmottagning
city: Lerum
country: Sweden
facility: Närhälsan Lerum Rehabmottagning
Study officials:
affiliation: Närhälsan Rehabilitering
name: Anette Larsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: