Muscle Strength and Total Knee Replacement

NCT05248815 | Completed

• 1 other identifier: Muscle strength and TKP
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthropathy of Knee; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

• 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

• 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 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

• 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

Study Arms (1)

Study group

Patients scheduled for total knee replacement.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Alingsås Hospital which is located in the Västra Götaland Region of Sweden.

You may qualify if:

• Scheduled for total knee replacement on the basis of osteoarthritis of the knee
• Expected rehabilitation in a primary care setting

You may not qualify if:

• Difficulties reading or speaking Swedish
• Revision surgery
• Rehabilitation in other settings than primary care

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (3)

Närhälsan Sörhaga Rehabmottagning

Alingsås, Sweden

Location

Närhälsan Herrljunga Rehabmottagning

Herrljunga, Sweden

Location

Närhälsan Lerum Rehabmottagning

Lerum, Sweden

Location

Study Officials

• Anette Larsson, PhD

  Närhälsan Rehabilitering

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: November 12, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)