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Weight loss before knee surgery shows promise in small trial

NCT ID NCT05853497

Symptom relief Sponsor: University of Kansas Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This pilot study tested whether a weight loss program before total knee replacement helps improve recovery. 24 adults with obesity (BMI 35-40) were assigned to either a very low-calorie diet with health coaching or standard care. The goal was to see if the program was feasible and could reduce pain and improve knee function after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multi-Component Weight Loss Intervention (behavioral: very low-calorie diet, health coaching, physical activity)
What this could lead to
If it works, this could point toward a standard weight loss program before knee replacement to improve outcomes like pain and function.
What could go wrong
This is a very small pilot study (24 people) testing feasibility, not effectiveness. Results may not apply to everyone, and the strict diet may be hard to follow.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

May 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder osteoarthritis susceptibility 6 osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthropathy of knee Obesity

Contacts and locations

Locations

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.