Weight Loss Intervention for Obesity Before Knee Surgery

Overseen by Steve Herrmann, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if losing weight before knee surgery and maintaining it afterward can improve recovery for patients with high BMI. The program includes a strict diet before surgery and a regular diet after, along with exercise and counseling. The goal is to see if this approach reduces complications and improves outcomes.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does list certain health conditions that would exclude you from participating, such as untreated hyperuricemia, active inflammatory bowel disease, and others. It's best to discuss your specific medications with the trial coordinators.

What data supports the idea that Weight Loss Intervention for Obesity Before Knee Surgery is an effective treatment?

The available research shows that weight loss interventions before knee surgery can lead to significant weight loss and improvements in health-related quality of life and knee function. One study found that patients lost an average of 10.7 kg before surgery and maintained this weight loss a year after surgery, while also improving their body composition and reducing cardiovascular risk factors. Another study indicated that weight loss diets before surgery resulted in an average weight loss of 6.67 kg. However, these interventions did not significantly reduce postoperative complications or hospital stay length. Overall, the data suggests that weight loss interventions can be effective in improving certain health outcomes for patients undergoing knee surgery. ^{1 2 3 4 5}

What safety data exists for weight loss treatments before knee surgery?

The safety data for weight loss treatments before knee surgery includes findings from several studies. A randomized trial showed that both intermittent low-energy diets (LED) and daily meal replacements maintained weight loss over three years without significant differences in knee replacement rates. A systematic review found low-quality evidence that preoperative weight-loss diets do not significantly reduce postoperative complications or hospital stay length. A retrospective cohort study suggested that a dietitian-led very low-calorie diet might reduce perioperative risks, although evidence is limited. Overall, while weight loss is achieved, the impact on surgical outcomes and safety is not conclusively established. ^{2 5 6 7 8}

Is the Multi-Component Weight Loss Intervention a promising treatment for obesity before knee surgery?

Yes, the Multi-Component Weight Loss Intervention is promising because it helps patients lose weight before knee surgery, which can improve their overall health and maintain weight loss after surgery. This can lead to better quality of life and knee function. ^{1 2 3 9 10}

Research Team

Steve Herrmann, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for individuals aged 50-75 with a BMI of 35 to ≤40 kg/m2, scheduled for total knee replacement surgery at KUOrtho and able to participate in remote sessions via Bluetooth-enabled devices. It's not suitable for those outside this age and BMI range or without the required technology.

Inclusion Criteria

I am a patient at KUOrtho and meet all requirements for knee replacement surgery.

I own a device capable of telehealth sessions and syncing with health monitors.

My knee replacement surgery is scheduled for 3 months or more from now.

Treatment Details

Interventions

• Multi-Component Weight Loss Intervention (Behavioral Intervention)

Trial Overview The study tests a weight loss program before knee surgery, including a very low-calorie diet and behavior counseling, followed by a maintenance diet after surgery. Participants are randomly assigned to either this intervention or standard care without dietary advice.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Multi-component weight loss intervention

Group II: Standard Care Control Active Control 1 Intervention

Standard care

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

South Dakota State University

Collaborator

Trials

21

Recruited

10,100+

Findings from Research

An 8-week low-energy diet before total knee replacement led to an average weight loss of 10.7 kg in patients, which was maintained one year after surgery, indicating the feasibility and safety of preoperative weight loss interventions.

While both groups showed improvements in quality of life and knee function after surgery, there were no statistically significant differences between the diet and control groups, suggesting that while weight loss is beneficial, it may not directly translate to better functional outcomes compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention Before Total Knee Replacement: A 12-Month Randomized Controlled Trial. Liljensøe, A., Laursen, JO., Bliddal, H., et al.[2022]

A systematic review of three studies involving 173 participants found that low-calorie diets before elective surgery led to a significant preoperative weight loss of about 6.67 kg compared to standard care.

However, the evidence suggests that these preoperative weight-loss diets do not significantly reduce postoperative complications or the length of hospital stay, indicating that while they may help with weight loss, they do not improve overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of weight-loss diets prior to elective surgery on postoperative outcomes in obesity: A systematic review and meta-analysis. Pavlovic, N., Boland, RA., Brady, B., et al.[2022]

A seven-year follow-up study of 49 patients who underwent total knee arthroplasty (TKA) found that those who participated in a preoperative weight loss program could not maintain their weight loss long-term, gaining an average of 3.1 kg more than the control group.

Despite the inability to maintain weight loss, both groups showed significant improvements in pain, knee function, and health-related quality of life after TKA, indicating that weight loss prior to surgery may still have short-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after weight loss intervention in knee arthroplasty patients with obesity. Thomasen, A., Mechlenburg, I., Laursen, JO., et al.[2022]

A very low calorie diet (VLCD) program for 46 adults with obesity awaiting elective surgery resulted in significant weight loss (average -6.5 kg) compared to standard care, which showed no weight loss (+0.15 kg).

The VLCD program also led to a greater reduction in waist circumference and improved quality of life, all while maintaining muscle mass, indicating its feasibility and effectiveness as a pre-operative intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a very low calorie diet program into the pre-operative model of care for obese general elective surgery patients: Outcomes of a feasibility randomised control trial. Hollis, G., Franz, R., Bauer, J., et al.[2021]

In a study of 40 obese patients with chronic osteoarthritis, those who followed a hypocaloric diet using the Optisource® formula lost significantly more weight and fat mass compared to those receiving conventional dietary advice, with an average weight loss of -7.56 kg versus -5.18 kg after 3 months.

Both groups had similar outcomes regarding post-surgical complications and recovery times, indicating that the hypocaloric formula did not negatively impact surgical safety while providing better metabolic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a commercial hypocaloric diet in weight loss and post surgical morbidities in obese patients with chronic arthropathy, a randomized clinical trial. de Luis, DA., Izaola, O., García Alonso, M., et al.[2012]

In a 3-year randomized trial involving 153 participants with knee osteoarthritis, both intermittent low-energy diet (LED) and daily meal replacements effectively maintained weight loss after an initial average loss of 10.5 kg, challenging the belief that long-term weight regain is inevitable.

The study found no significant difference in the number of knee replacements between the two groups, indicating that both dietary strategies are safe and do not adversely affect the need for surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. Christensen, P., Henriksen, M., Bartels, EM., et al.[2023]

A multi-component dietary weight loss program, including a ketogenic very low calorie diet and video consultations, was well-received by 24 patients with knee osteoarthritis, highlighting its ease of use and convenience as key factors for adherence.

Support from dietitians and the program's holistic approach, which included educational resources and exercise, were crucial for participants' success, leading to improved knee pain and function over the 6-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. Lawford, BJ., Bennell, KL., Jones, SE., et al.[2021]

A dietitian-led preoperative very low calorie diet resulted in clinically significant weight loss (average of 7.1 kg) for 141 patients with obesity, which improved their American Society of Anesthesiologists scores and reduced estimated surgical risks.

The median risk of serious postoperative complications decreased from 4.8% to 3.9% and the risk of any complications from 6% to 5.1%, indicating that this dietary intervention may enhance safety for patients undergoing non-bariatric elective surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a dietitian-led very low calorie diet clinic on perioperative risk for patients with obesity awaiting elective, non-bariatric surgery: A retrospective cohort study. Griffin, SB., Palmer, MA., Strodl, E., et al.[2023]

A preoperative very low-calorie diet (VLCD) led to modest weight loss in patients preparing for bariatric surgery, with an average loss of 4.4% in those with a BMI ≥ 50 kg/m² and 3.8% in those with a BMI < 50 kg/m², indicating its effectiveness across different BMI groups.

The study found high patient compliance (75.5% for BMI < 50 kg/m² and 61.8% for BMI ≥ 50 kg/m²) and overall acceptability of the liquid diet, suggesting that patients were generally satisfied with the regimen despite some differences in hunger levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, Compliance, and Acceptability of Preoperative Weight Loss with a Liquid Very Low-Calorie Diet Before Bariatric Surgery in Real Practice. Yolsuriyanwong, K., Thanavachirasin, K., Sasso, K., et al.[2020]

Obesity significantly increases the risk of complications during and after total joint arthroplasty (TJA), including longer surgery times, higher hospitalization costs, and greater chances of infections and other serious issues.

Only 7% of patients denied TJA due to severe obesity were able to lose enough weight to qualify for surgery through lifestyle changes, highlighting the need for effective preoperative weight loss strategies, such as mobile health interventions, to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity, preoperative weight loss, and telemedicine before total joint arthroplasty: a review. Seward, MW., Chen, AF.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Weight Loss Intervention Before Total Knee Replacement: A 12-Month Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effect of weight-loss diets prior to elective surgery on postoperative outcomes in obesity: A systematic review and meta-analysis. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Long-term results after weight loss intervention in knee arthroplasty patients with obesity. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Implementation of a very low calorie diet program into the pre-operative model of care for obese general elective surgery patients: Outcomes of a feasibility randomised control trial. [2021]

5. Italy pubmed.ncbi.nlm.nih.gov

Effect of a commercial hypocaloric diet in weight loss and post surgical morbidities in obese patients with chronic arthropathy, a randomized clinical trial. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

"It's the single best thing I've done in the last 10 years": a qualitative study exploring patient and dietitian experiences with, and perceptions of, a multi-component dietary weight loss program for knee osteoarthritis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a dietitian-led very low calorie diet clinic on perioperative risk for patients with obesity awaiting elective, non-bariatric surgery: A retrospective cohort study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness, Compliance, and Acceptability of Preoperative Weight Loss with a Liquid Very Low-Calorie Diet Before Bariatric Surgery in Real Practice. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Obesity, preoperative weight loss, and telemedicine before total joint arthroplasty: a review. [2022]