Return to Physical Activities After Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03039907
• Other study ID #: TKAUnder65-001
• Status: Recruiting
• Start date: January 23, 2017
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2020
• Source: Cincinnati Sportsmedicine Research and Education Foundation
• Contact: Frank R Noyes, MD
• Phone: 513-347-9999
• Email: frnoyes[@]gmaili.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Procedure:
• Total Knee Arthroplasty
Total knee arthroplasty

Locations

Country	Name	City	State
United States	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Cincinnati Sportsmedicine Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Number of Participants That Return to Recreational and Fitness Activities	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.	2 years postoperatively
Secondary	Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities	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 years postoperatively
Secondary	Assessment of Postoperative Complications on Return to Recreational and Physical Activities	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.	2 years postoperatively
Secondary	Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities	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.	2 years postoperatively