Arthropathy of KneeNCT05853497
A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement
A study testing Multi-Component Weight Loss Intervention in people with Arthropathy of Knee and Obesity, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Arthropathy of Knee, Obesity
- What is being tested?
- Multi-Component Weight Loss Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Arthropathy of Knee, Obesity
- Being tested
- Multi-Component Weight Loss Intervention
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Component Weight Loss InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Control | No intervention | Standard care |
| Intervention | Experimental | Multi-component weight loss intervention Receives: Behavioral: Multi-Component Weight Loss Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention Feasibility
Feasibility will be based on retention of ≥ 80% participants (i.e., <20% participant dropout).
Measured: 6 Months
Participant Attendance Feasibility
Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.
Measured: 6 Months
Secondary outcomes (5)
Knee and Lower Extremity Physical Function (OARSI Test)
Knee and lower extremity function will be compared between study arms using the Osteoarthritis Research Society International (OARSI) physical function test battery.
Measured: 6 Months
Fat Mass (kg)
Changes in fat mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)
Measured: 6 Months
Fat Free Mass (kg)
Changes in fat free mass (kg) will be compared between study arms using dual x-ray absorptiometry (DEXA)
Measured: 6 Months
Body Weight (kg)
Changes in body weight (kg) will be compared between study arms using a calibrated body weight scale.
Measured: 6 Months
Self reported knee function
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 May 2023
- Primary completion30 Apr 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- South Dakota State University
- Responsible party
- Sponsor
- Investigators
- Steve Herrmann, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853497
- Sponsor's protocol ID
- STUDY00149595
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2023
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Component Weight Loss Intervention to Improve Outcomes of Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05853497
- Acronym / sponsor ID
- STUDY00149595
- Conditions
- Arthropathy of Knee, Obesity
- Keywords
- Total Knee Arthroplasty, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- South Dakota State University
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Control | No intervention | –Standard care |
| Intervention | Experimental | Behavioral: Multi-Component Weight Loss InterventionMulti-component weight loss intervention |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Component Weight Loss InterventionThe 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. | Behavioural | Intervention |
Primary outcome
Participant Retention Feasibility
Time frame: 6 Months
Feasibility will be based on retention of ≥ 80% participants (i.e., <20% participant dropout).
Participant Attendance Feasibility
Time frame: 6 Months
Feasibility will be based on ≥ 80% attendance at behavioral counseling sessions.
5 secondary outcomes
Knee and Lower Extremity Physical Function (OARSI Test)
Time frame: 6 Months
Fat Mass (kg)
Time frame: 6 Months
Fat Free Mass (kg)
Time frame: 6 Months
Body Weight (kg)
Time frame: 6 Months
Self reported knee function
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Herrmann, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Component Weight Loss Intervention in people with Arthropathy of Knee and Obesity, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Feasibility (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.