Clinical trial NCT05853497: A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement
Official title: A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arthropathy of Knee
Obesity
Keywords: Total Knee Arthroplasty
Total Knee Replacement
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: South Dakota State University
First posted: 2023-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age: 50-75 years
* BMI: 35 to ≤40 kg/m2
* Patient of KU Health System Department of Orthopedics and Sports Medicine (KUOrtho)meeting all requirements for TKA surgery.
* TKA surgical date scheduled ≥3 mos. from consent
* Own a Bluetooth enabled computer, tablet, or smart phone with the ability to join remote telehealth sessions and sync study self-monitoring devices.

Exclusion Criteria:

* Weight loss ≥10 pounds in previous 6 months
* Dairy/milk protein allergy
* Currently pregnant/breastfeeding or planning to become pregnant during the study
* Currently being treated for an eating disorder or history of an eating disorder diagnosis
* Pacemaker
* Current Cancer
* Diabetes Type 1 (insulin dependent)
* Hyperuricemia (untreated)
* Inflammatory bowel disease (active)
* Liver disease requiring protein restriction
* Myocardial infarction within last 3 months
* Abnormal ECG
* Renal insufficiency.

Primary outcomes:
measure: Participant Retention Feasibility
timeFrame: 6 Months
measure: Participant Attendance Feasibility
timeFrame: 6 Months
Secondary outcomes:
measure: Knee and Lower Extremity Physical Function (OARSI Test)
timeFrame: 6 Months
measure: Fat Mass (kg)
timeFrame: 6 Months
measure: Fat Free Mass (kg)
timeFrame: 6 Months
measure: Body Weight (kg)
timeFrame: 6 Months
measure: Self reported knee function
timeFrame: 6 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Steve Herrmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: