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
|Condition or disease||Intervention/treatment|
|Arthroplasty, Replacement, Knee||Procedure: Total Knee Arthroplasty|
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]|
|Estimated Enrollment :||150 participants|
|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|
- Procedure: Total Knee Arthroplasty
Total knee arthroplasty
- 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.
- 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.
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
|Contact: Frank R Noyes, MDemail@example.com|
|Contact: Cassie Fleckenstein, MSfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Sportsmedicine and Orthopaedic Center||Recruiting|
|Cincinnati, Ohio, United States, 45242|
|Contact: Cassie Fleckenstein, M.S. 513-794-8466 email@example.com|
|Principal Investigator: Frank Noyes, M.D.|
|Principal Investigator:||Frank R Noyes, MD||Cincinnati Sportsmedicine and Orthopaedic Center|