Muscle Strength and Total Knee Replacement

Osteo Arthritis Knee Clinical Trial

Official title:

Knee Extensor Muscle Strength and Physical Function Before and After Total Knee Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05248815
• Other study ID #: Muscle strength and TKP
• Status: Active, not recruiting
• Start date: November 12, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Knee
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Sweden	Närhälsan Sörhaga Rehabmottagning	Alingsås
Sweden	Närhälsan Herrljunga Rehabmottagning	Herrljunga
Sweden	Närhälsan Lerum Rehabmottagning	Lerum

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Comparison of data before surgery (0-2 weeks) with data 3, 6 and 12 months after surgery
Primary	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.	Comparison of data before surgery (0-2 weeks) with data data from the control group
Primary	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.	Comparison of data one year after surgery with data data from the control group
Primary	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.	Before surgery (0-2 weeks). 3, 6 and 12 months after surgery.
Secondary	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.	Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Secondary	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.	Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Secondary	Comparison of 6-min walk test between study group and control group		Comparison of data for the study group from before surgery (0-2 weeks) and 12 months after surgery with data from the control group
Secondary	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.	Before surgery (0-2 weeks) and 12 months after surgery
Secondary	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.	Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 12 months after surgery