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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 : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation

Tracking Information
First Submitted Date April 11, 2016
First Posted Date February 1, 2017
Last Update Posted Date July 31, 2019
Actual Study Start Date January 23, 2017
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 31, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 31, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Return to Physical Activities After Total Knee Arthroplasty
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
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition Arthroplasty, Replacement, Knee
Intervention Procedure: Total Knee Arthroplasty
Total knee arthroplasty
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 31, 2017)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Frank R Noyes, MD 513-347-9999 frnoyes@gmaili.com
Contact: Cassie Fleckenstein, MS 513-792-3232 cfleckenstein@csmref.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03039907
Other Study ID Numbers TKAUnder65-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
Study Sponsor Cincinnati Sportsmedicine Research and Education Foundation
Collaborators Not Provided
Investigators
Principal Investigator: Frank R Noyes, MD Cincinnati Sportsmedicine and Orthopaedic Center
PRS Account Cincinnati Sportsmedicine Research and Education Foundation
Verification Date July 2019