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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04746144
Other study ID # TKRActivity13-15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2013
Est. completion date January 1, 2021

Study information

Verified date February 2021
Source Cincinnati Sportsmedicine Research and Education Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 1, 2021
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 69 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Total knee arthroplasty


Locations

Country Name City State
United States Cincinnati Sportsmedicine and Orthopaedic Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Cincinnati Sportsmedicine Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Preoperative
Primary 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. 4 years postoperative
Primary 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?" 4 years postoperative
Secondary 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 Preoperative
Secondary 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 4 years postoperative
Secondary 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) Preoperative
Secondary 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) 4 years postoperative
Secondary 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 Preoperative
Secondary 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 4 years postoperative
Secondary Aerobic fitness levels 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
Preoperative
Secondary Aerobic fitness levels 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
4 years postoperative
Secondary Work Status Single question: Are you able to work:
Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
Preoperative
Secondary Work Status Single question: Are you able to work:
Patients select: Yes, with no limitations; Yes, with limitations; No, Retired or does not apply
4 years postoperative
Secondary Patient Expectations After Surgery 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
4 years postoperative
Secondary Patient Expectations Before Surgery 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
Preoperative
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