Return Physical Activities After Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746144
• Other study ID #: TKRActivity13-15
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

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