Return Physical Activities After Total Knee Arthroplasty

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Sportsmedicine and Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients were selected from the treating surgeon's patient 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  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
Preoperative
Aerobic fitness levels
Time Frame: 4 years postoperative

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
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:

  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

4 years postoperative
Patient Expectations Before Surgery
Time Frame: Preoperative

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

Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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