Return to Physical Activities After Total Knee Arthroplasty

A Critical Assessment of the Factors That Promote or Limit the Return to Recreational, Work, and Physical Fitness Activities After Primary Total Knee Arthroplasty

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.

Study Overview

• Status: Unknown
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Cincinnati Sportsmedicine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2017
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Replacement; Knee
• Other Study ID Numbers: TKAUnder65-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES