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Completed

NCT Number: NCT04746144

Return Physical Activities After Total Knee Arthroplasty

The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.

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Key information

Conditions

Total Knee Arthroplasty

Age range

Up to 69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

About this study

A prospective study was conducted in patients who underwent primary TKA (Journey II, Smith & Nephew) from the same surgeon from July 1, 2013 to December 31, 2015. Patients completed patient-reported outcome measures (PROMs) before the operation and then at 1, 2, and 4 years postoperatively.These included the Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS JR) 7-item score; questions from the Cincinnati Knee Rating System related to the overall knee condition, pain, and swelling; selected questions from the Veterans RAND 12-Item Health Survey; questions about general fitness level; and questions regarding patient expectations before and after surgery. Patients were asked to list all physical, recreational, and work activities they participated in after surgery. An experienced research associate interviewed the patients postoperatively, with data reduction and patient ratings blinded to the treating surgeon and therapist.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age < 70 years
  • Patient goals to return to recreational and occupational activities
  • Agree to participate in a postoperative rehabilitation and home exercise program

Exclusion criteria

  • Osteoarthritis in other joints
  • Co-morbidities limiting physical activity
  • Presence of a connective tissue disease
  • Autoimmune disease or immune deficiency
  • Age 70 years or more
  • no desire to return to recreational and work activities
  • Refusal to participate in rehabilitation program

Treatment and study plan

Total knee arthroplasty

Procedure

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score

    Time frame: Preoperative

    Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.

  2. Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score

    Time frame: 4 years postoperative

    Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.

  3. Documentation of sports and recreational activities

    Time frame: 4 years postoperative

    Patients provide a list of all sports and recreational activities they participated in after surgery. This is an open-ended question "What sports or recreational activities do you participate in on a regular basis?"

Secondary outcomes

  1. Cincinnati Knee Rating Pain Score

    Time frame: Preoperative

    Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe pain constant with daily activities, 2 = moderate pain with activities of daily living, 4 = able to do activities of daily living with no pain, and 6 = no pain with recreational activities

  2. Cincinnati Knee Rating Pain Score

    Time frame: 4 years postoperative

    Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe pain constant with daily activities, 2 = moderate pain with activities of daily living, 4 = able to do activities of daily living with no pain, and 6 = no pain with recreational activities

  3. Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score

    Time frame: Preoperative

    Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)

  4. Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score

    Time frame: 4 years postoperative

    Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)

  5. Cincinnati Knee Rating Swelling Score

    Time frame: Preoperative

    Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe swelling constant with daily activities, 2 = moderate swelling with activities of daily living, 4 = able to do activities of daily living with no swelling, and 6 = no swelling with recreational activities

  6. Cincinnati Knee Rating Swelling Score

    Time frame: 4 years postoperative

    Scored on a point scale where patient selects 0, 2, 4, or 6; where 0 = severe swelling constant with daily activities, 2 = moderate swelling with activities of daily living, 4 = able to do activities of daily living with no swelling, and 6 = no swelling with recreational activities

  7. Aerobic fitness levels

    Time frame: Preoperative

    Two questions are completed:

    • Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week?
    • Are you able to spend 20 minutes doing vigorous aerobic activity that causes a large increase in your heart rate 3 days a week? Scale for both questions: Yes; No, because of pain in my knee; No, because of pain in another joint; No, because of other reasons

  8. Aerobic fitness levels

    Time frame: 4 years postoperative

    Two questions are completed:

    • Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week?
    • Are you able to spend 20 minutes doing vigorous aerobic activity that causes a large increase in your heart rate 3 days a week? Scale for both questions: Yes; No, because of pain in my knee; No, because of pain in another joint; No, because of other reasons

  9. Work Status

    Time frame: Preoperative

    Single question: Are you able to work:

    Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply

  10. Work Status

    Time frame: 4 years postoperative

    Single question: Are you able to work:

    Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply

  11. Patient Expectations After Surgery

    Time frame: 4 years postoperative

    4 questions:

    • My expectations for being able to do my normal activities of daily living after the knee surgery were:
    • My expectations for being able to do my leisure, recreational or sports activities after the knee surgery were:

    Scale for first 2 questions: Too low, I'm a lot better than I thought; Too low, I'm somewhat better than I thought; Just right, my expectations were met; Too high, I'm somewhat worse than I thought; Too high, I'm a lot worse than I thought.

    • Was your surgery worthwhile; are you glad you underwent the procedure? Scale: Yes, definitely; Yes, probably; No, probably; No, definitely
    • Compare the overall condition of your knee now to what it was before your surgery.

    Scale: Great deal better, Somewhat better, The same, Somewhat worse, Great deal worse

  12. Patient Expectations Before Surgery

    Time frame: Preoperative

    2 questions:

    • I expect that, after my knee surgery, activities such as walking, stairs, and kneeling to be:
    • I expect that, after my knee surgery, recreational activities such as bicycling, hiking, golf, light tennis, to be:

    Scale for both questions: Fully normal with no limitation; Almost normal with some limitations; Improved, but may have some problems; Improved, but may have bothersome problems; Not possible or not interested in recreational activities

Sponsors and collaborators

Lead sponsor

Cincinnati Sportsmedicine Research and Education Foundation

Other

Registry information

Official study title

Return to Physical Activities and Aerobic Fitness After Total Knee Arthroplasty in Younger Patients

Important dates

Study start
2013
Primary completion
2015
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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