University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT05853497
Obesity, specifically BMIs ≥35 or 40 kg/m2, are associated with an increased probability of poor outcomes of Total Knee Arthroplasty (TKA) including increased pain, risk for infection, poor joint function, and increased rates of hospital readmissions. Several orthopedic and public health organizations recommend weight loss prior to TJA for individuals with overweight/obesity. However, empirical evidence suggesting the effectiveness of pre-surgical weight loss on surgical and functional outcomes of TKA is extremely limited and is based primarily on non-randomized observational studies. Thus, to gain further insight regarding the feasibility and potential effectiveness of pre-surgical weight loss on outcomes of TKA, the proposed pilot trial will randomize 30 patients (age 50-75 yrs., BMI 35<40 kg/m2) scheduled for TKA through The University of Kansas Health System Department of Orthopedics and Sports Medicine (KUOrtho) to a multi-component weight loss (3-mo. pre-TKA, very low-calorie diet) and maintenance intervention (3-mo. post TKA, conventional maintenance diet) or standard care control which will include no dietary or weight loss advice. The weight loss/maintenance interventions will include reduced energy intake or energy intake prescribed for weight loss maintenance, increased physical activity, and individual behavior counseling. Outcomes will be assessed 1) baseline, i.e., 3 mos. prior to surgery, 2) 3 mos. i.e., at the completion of the weight loss intervention prior to TKA, 3) within a minimum of 2 weeks post TKA, and 4) 3 mos. post-TKA, i.e., after completion of the weight maintenance intervention to assess the feasibility and effectiveness of a remotely delivered multi-component pre-TKA weight loss and a post-TKA weight maintenance intervention.
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Notify Me50 year–75 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention group will receive weekly 1-on-1 health coaching with a very-low calorie nutrition plan prior to total knee replacement and a conventional weight maintenance nutrition plan after surgery.
Time frame: 6 Months
Feasibility will be based on retention of ≥ 80% participants (i.e., <20% participant dropout).
Time frame: 6 Months
Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.
Time frame: 6 Months
Knee and lower extremity function will be compared between study arms using the Osteoarthritis Research Society International (OARSI) physical function test battery.
Time frame: 6 Months
Changes in fat mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)
Time frame: 6 Months
Changes in fat free mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)
Time frame: 6 Months
Changes in body weight (kg) will be compared between study arms using a calibrated body weight scale.
Time frame: 6 Months
Self-reported knee function will be compared between study arms using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
University of Kansas Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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