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NCT Number: NCT05248815

Muscle Strength and 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.

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Key information

Conditions

Arthropathy of Knee Osteo Arthritis Knee

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Närhälsan Sörhaga Rehabmottagning, Alingsås, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

    30 s chair stand test measures the number of complete stands the test person is able to perform within 30 s.

  2. 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

    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.

  3. 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

  4. 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

    Physical activity level will be measured as activity minutes using a questionnaire.

  5. 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

    Satisfaction will be measured using a 4-point likert scale.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2022
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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