Knee Osteoarthritis, Obesity
Conditions
Keywords
total knee replacement, obesity, total joint replacement, bioimpedance, orthopedics, body composition, fitness tracker
Brief summary
Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have been suggested as ineffective and counterproductive. Furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. At the University of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers, and BIA has recently been incorporated into wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA. This study, a randomized controlled trial, aims to recruit adult patients with class III obesity presenting to the arthroplasty-obesity clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable BIA wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching. This study aims to identify if the use of a wearable BIA wristband aids in the desired body composition changes. In addition, this study aims to quantify the body composition changes exhibited by each cohort. Finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.
Interventions
DEVICEInBody Band 2
Wearable bioimpediance monitor similar to a fitness watch.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adults \>/= 18 years * BMI \> 40kg/m2 * Presenting to bariatric arthroplasty clinic with desire for total joint arthroplasty procedure * Owns a smartphone capable of handling iOS or Google Play apps * Has a wrist circumference less than or equal to 7.7"
Exclusion criteria
* Has a pacemaker or other electronic pacemaker placement * Inability to complete study protocols * Inability to stand unsupported for 60-90 seconds * Does not own a smart phone capable of handling iOS or Google Play apps * Has a wrist circumference greater than 7.7"
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Elkins, MD
University of Iowa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wearable Device Group Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch. | 30 |
| Control Group Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. | 30 |
| Total | 60 |
Outcome results
Primary
Device Impact on Length of Time Until Surgical Indication
In this RCT, we analyzed the impact of the wearable device (band) on length of time until surgical indication
Time frame: Maximum 12 months prior to TJA
Population: 6 total subjects were indicated for surgery. 3 per group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Wearable Device Group | Device Impact on Length of Time Until Surgical Indication | 3.7 months |
| Control Group | Device Impact on Length of Time Until Surgical Indication | 8.7 months |
Comparison: Power calculation: 2 factor (group, time) ANOVA design with a group\*time interaction term to estimate the proposed sample size. Using a Cohen's effect size estimate for 2 groups with 5 time-points, a sample size of 40 per group will provide \>90% to detect a moderate effect size (0.25) for group, for time and for the group\*time interaction.p-value: 0.06429t-test, 2 sided
Secondary
Body Composition Changes Quantified
Body mass change, fat mass change, skeletal muscle mass change
Time frame: Maximum 12 months prior to TJA
Secondary
Surgical Outcomes
Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.
Time frame: 24 months postoperatively