Clinical trial NCT04746144: Return Physical Activities After Total Knee Arthroplasty
Official title: Return to Physical Activities and Aerobic Fitness After Total Knee Arthroplasty in Younger Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Arthroplasty
Lead sponsor: Cincinnati Sportsmedicine Research and Education Foundation
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 51
Sex: ALL
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were selected from the treating surgeon's patient population.

Brief summary: The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.

Detailed description: A prospective study was conducted in patients who underwent primary TKA (Journey II, Smith \& Nephew) from the same surgeon from July 1, 2013 to December 31, 2015. Patients completed patient-reported outcome measures (PROMs) before the operation and then at 1, 2, and 4 years postoperatively.These included the Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS JR) 7-item score; questions from the Cincinnati Knee Rating System related to the overall knee condition, pain, and swelling; selected questions from the Veterans RAND 12-Item Health Survey; questions about general fitness level; and questions regarding patient expectations before and after surgery. Patients were asked to list all physical, recreational, and work activities they participated in after surgery. An experienced research associate interviewed the patients postoperatively, with data reduction and patient ratings blinded to the treating surgeon and therapist.

Eligibility criteria: Inclusion Criteria:

* Age \< 70 years
* Patient goals to return to recreational and occupational activities
* Agree to participate in a postoperative rehabilitation and home exercise program

Exclusion Criteria:

* Osteoarthritis in other joints
* Co-morbidities limiting physical activity
* Presence of a connective tissue disease
* Autoimmune disease or immune deficiency
* Age 70 years or more
* no desire to return to recreational and work activities
* Refusal to participate in rehabilitation program

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
timeFrame: Preoperative
measure: Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score
timeFrame: 4 years postoperative
measure: Documentation of sports and recreational activities
timeFrame: 4 years postoperative
Secondary outcomes:
measure: Cincinnati Knee Rating Pain Score
timeFrame: Preoperative
measure: Cincinnati Knee Rating Pain Score
timeFrame: 4 years postoperative
measure: Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
timeFrame: Preoperative
measure: Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score
timeFrame: 4 years postoperative
measure: Cincinnati Knee Rating Swelling Score
timeFrame: Preoperative
measure: Cincinnati Knee Rating Swelling Score
timeFrame: 4 years postoperative
measure: Aerobic fitness levels
timeFrame: Preoperative
measure: Aerobic fitness levels
timeFrame: 4 years postoperative
measure: Work Status
timeFrame: Preoperative
measure: Work Status
timeFrame: 4 years postoperative
measure: Patient Expectations After Surgery
timeFrame: 4 years postoperative
measure: Patient Expectations Before Surgery
timeFrame: Preoperative
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: