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Completed

NCT Number: NCT05853497

A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement

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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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-Component Weight Loss Intervention

Behavioral

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.

Primary outcomes

  1. Participant Retention Feasibility

    Time frame: 6 Months

    Feasibility will be based on retention of ≥ 80% participants (i.e., <20% participant dropout).

  2. Participant Attendance Feasibility

    Time frame: 6 Months

    Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.

Secondary outcomes

  1. Knee and Lower Extremity Physical Function (OARSI Test)

    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.

  2. Fat Mass (kg)

    Time frame: 6 Months

    Changes in fat mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)

  3. Fat Free Mass (kg)

    Time frame: 6 Months

    Changes in fat free mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)

  4. Body Weight (kg)

    Time frame: 6 Months

    Changes in body weight (kg) will be compared between study arms using a calibrated body weight scale.

  5. Self reported knee function

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • South Dakota State University

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 10, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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