Muscle Strength and Total Knee Replacement

Active, not recruiting

• Conditions: Osteo Arthritis Knee; Arthropathy of Knee

• Registration Number: NCT05248815
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-12
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of knee extensor muscle strength of the affected side before surgery with controls	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.
Changes in knee extensor muscle strength of the affected side from before surgery to one year after surgery	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 one year after surgery with controls	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	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of 30 s chair stand 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	30 s chair stand test measures the number of complete stands the test person is able to perform within 30 s.
Comparison of Knee injury and Osteoarthritis Outcome Score 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	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 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
Correlation between changes in knee extensor muscle strength of the affected side before and after surgery with overall satisfaction one year after surgery	Changes in muscle strength from before surgery (0-2 weeks) and 12 months after surgery, satisfaction 12 months after surgery	Satisfaction will be measured using a 4-point likert scale.
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	Before surgery (0-2 weeks) and 12 months after surgery	Physical activity level will be measured as activity minutes using a questionnaire.

Trial Locations

Locations (3)

Närhälsan Sörhaga Rehabmottagning; 🇸🇪 Alingsås, Sweden

Närhälsan Herrljunga Rehabmottagning; 🇸🇪 Herrljunga, Sweden

Närhälsan Lerum Rehabmottagning; 🇸🇪 Lerum, Sweden