An observational study in Total Knee Arthroplasty, sponsored by Cincinnati Sportsmedicine Research and Education Foundation. Completed at 1 site in United States. Open to participants aged Up to 69 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Cincinnati Sportsmedicine Research and Education Foundation · Observational
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.
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.
Cincinnati Sportsmedicine Research and Education Foundation is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients were selected from the treating surgeon's patient population.
Exclusion Criteria:
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Time frame: Preoperative
Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.
Time frame: 4 years postoperative
Documentation of sports and recreational activities
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?"
Time frame: 4 years postoperative
Cincinnati Knee Rating Pain Score
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
Time frame: Preoperative
Cincinnati Knee Rating Pain Score
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
Time frame: 4 years postoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)
Time frame: Preoperative
Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
Score for the patient rating of the overall knee condition (0-10 point scale where 0 = poor and 10 = excellent)
Time frame: 4 years postoperative
Cincinnati Knee Rating Swelling Score
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
Time frame: Preoperative
Cincinnati Knee Rating Swelling Score
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
Time frame: 4 years postoperative
Aerobic fitness levels
Two questions are completed: 1. Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week? 2. 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
Time frame: Preoperative
Aerobic fitness levels
Two questions are completed: 1. Are you able to take a brisk 20-minute walk that raises your heart rate 5 days a week? 2. 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
Time frame: 4 years postoperative
Work Status
Single question: Are you able to work: Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
Time frame: Preoperative
Work Status
Single question: Are you able to work: Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
Time frame: 4 years postoperative
Patient Expectations After Surgery
4 questions: 1. My expectations for being able to do my normal activities of daily living after the knee surgery were: 2. 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. 3. Was your surgery worthwhile; are you glad you underwent the procedure? Scale: Yes, definitely; Yes, probably; No, probably; No, definitely 4. 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
Time frame: 4 years postoperative
Patient Expectations Before Surgery
2 questions: 1. I expect that, after my knee surgery, activities such as walking, stairs, and kneeling to be: 2. 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
Time frame: Preoperative
Plan to share: No
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Cincinnati Sportsmedicine Research and Education Foundation