Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Return to Physical Activities After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03039907
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Procedure: Total Knee Arthroplasty

Detailed Description:

There are three purposes of this study. The first purpose is to examine the factors that allow patients that underwent total knee arthroplasty with the Journey II to return to recreational sports and/or work activities, and to achieve recommended physical activity levels (defined by the American Heart Association and the American College of Sports Medicine).

The second purpose is to examine the factors that limit the ability of patients to resume sports, work, and physical fitness training, including comorbidities, general health, complications, and other factors.

The third purpose is to use advanced sports medicine rehabilitation principles that involve staged progressive protocols to safely prepare patients for sports, work, and physical fitness training. Objective measurements of muscle strength, endurance, balance, and neuromuscular control will be used to determine when patients may be cleared to participate in these activities.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty
Actual Study Start Date : January 23, 2017
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: Total Knee Arthroplasty
    Total knee arthroplasty

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Analysis of Number of Participants That Return to Recreational and Fitness Activities [ Time Frame: 2 years postoperatively ]
    Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.


Secondary Outcome Measures :
  1. Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities [ Time Frame: 2 years postoperatively ]
    Patient comorbidities will be documented by the surgeon using the weighted Charlson Comorbidity Index. An analysis will be conducted to determine if the index score has a deleterious effect on recreational activities or general fitness activities at follow-up.

  2. Assessment of Postoperative Complications on Return to Recreational and Physical Activities [ Time Frame: 2 years postoperatively ]
    All postoperative complications will be documented in the study patient registry with a list related specifically to TKA from the AKS and a second general list that was generated from complications recorded by the Centers for Medicare and Medicaid Services (2015 update). An analysis will be conducted to determine if complications have a deleterious effect on recreational activities or general fitness activities patients return to after surgery.

  3. Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities [ Time Frame: 2 years postoperatively ]
    Patient body mass index will be collected before surgery and will be designated as either obese, over weight, or within normal limits according to WHO classification of obesity. Determination will be made of the effect of BMI on return to recreational or general fitness activities at follow-up.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients 65 years of age and younger who undergo total knee arthroplasty who desire to return to recreational (sports) and/or work activities postoperatively.
Criteria

Inclusion Criteria:

  • Men or women 65 years of age or younger.
  • Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
  • Patient provides informed consent.
  • Patient complies with postoperative rehabilitation program.

Exclusion Criteria:

  • Patient did not desire to return to recreational and/or work activities after TKA
  • History of alcohol or drug abuse within 3 years of the operation.
  • Disabling or widespread osteoarthritis or other joint disease in any other joint.
  • Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
  • Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039907


Contacts
Layout table for location contacts
Contact: Frank R Noyes, MD 513-347-9999 frnoyes@gmaili.com
Contact: Cassie Fleckenstein, MS 513-792-3232 cfleckenstein@csmref.org

Locations
Layout table for location information
United States, Ohio
Cincinnati Sportsmedicine and Orthopaedic Center Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Cassie Fleckenstein, M.S.    513-794-8466    cfleckenstein@csmref.org   
Principal Investigator: Frank Noyes, M.D.         
Sponsors and Collaborators
Cincinnati Sportsmedicine Research and Education Foundation
Investigators
Layout table for investigator information
Principal Investigator: Frank R Noyes, MD Cincinnati Sportsmedicine and Orthopaedic Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier: NCT03039907    
Other Study ID Numbers: TKAUnder65-001
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation:
Knee
Replacement