Clinical trial NCT03039907: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty, Replacement, Knee
Keywords: Knee
Replacement
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Analysis of Number of Participants That Return to Recreational and Fitness Activities
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities
timeFrame: 2 years postoperatively
measure: Assessment of Postoperative Complications on Return to Recreational and Physical Activities
timeFrame: 2 years postoperatively
measure: Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities
timeFrame: 2 years postoperatively
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Sportsmedicine and Orthopaedic Center
state: Ohio
Study officials:
affiliation: Cincinnati Sportsmedicine and Orthopaedic Center
name: Frank R Noyes, MD
role: PRINCIPAL_INVESTIGATOR
References: