- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746144
Return Physical Activities After Total Knee Arthroplasty
Return to Physical Activities and Aerobic Fitness After Total Knee Arthroplasty in Younger Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Cincinnati Sportsmedicine and Orthopaedic Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative
|
|
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.
|
4 years postoperative
|
|
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?"
|
4 years postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Preoperative
|
|
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
|
4 years postoperative
|
|
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)
|
Preoperative
|
|
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)
|
4 years postoperative
|
|
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
|
Preoperative
|
|
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
|
4 years postoperative
|
|
Aerobic fitness levels
Time Frame: Preoperative
|
Two questions are completed:
|
Preoperative
|
|
Aerobic fitness levels
Time Frame: 4 years postoperative
|
Two questions are completed:
|
4 years postoperative
|
|
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 |
Preoperative
|
|
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 |
4 years postoperative
|
|
Patient Expectations After Surgery
Time Frame: 4 years postoperative
|
4 questions:
Scale: Great deal better, Somewhat better, The same, Somewhat worse, Great deal worse |
4 years postoperative
|
|
Patient Expectations Before Surgery
Time Frame: Preoperative
|
2 questions:
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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TKRActivity13-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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