Osteoarthritis of KneePhase 4NCT06782529
Knee Injections for Obese Patients With Knee Arthritis
A Phase 4 study testing Triamcinolone Acetonide Low Dose and Triamcinolone Acetonide Standard Dose in people with Osteoarthritis of Knee, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Triamcinolone Acetonide Low Dose and Triamcinolone Acetonide Standard Dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2025to 24 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.
Who cannot join
- BMI < 30 kg/m2
- Uncontrolled diabetics with a hemoglobin A1c > 8%
- No other treatment within the time frame of the study.
- Patients that are undergoing physical therapy at the time of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Jeffrey P Nadwodny, DO, 904 953 6722, nadwodny.jeffrey@mayo.edu
Jeffrey P Nadwodny, DO
About this study
Official title: Comparison of Varying Doses of Steroid for Intra-articular Knee Injections
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.
- Conditions
- Osteoarthritis of Knee
- Being tested
- Triamcinolone Acetonide Low Dose, Triamcinolone Acetonide Standard Dose
- Keywords
- Knee Osteoarthritis, Corticosteroid Injection, Obesity
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide Low DoseDrug
Subjects will receive a reduced dose of 20mg of triamcinolone acetonide.
Total injection volume of 5ml, consisting of:
- 0.5ml triamcinolone acetonide (20mg)
- 4.5ml lidocaine (45mg)
Triamcinolone Acetonide Standard DoseDrug
Subjects will receive the standard of care dose of 40mg triamcinolone acetonide
Total injection volume of 5ml, consisting of:
- 1ml triamcinolone acetonide (40mg)
- 4ml lidocaine (40mg)
| Study group | Role | What they receive |
|---|---|---|
| Standard Dose Group | Active comparator | Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria. Receives: Drug: Triamcinolone Acetonide Standard Dose |
| Lower Dose Group | Experimental | Patients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria. Receives: Drug: Triamcinolone Acetonide Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale (NPS)
The Numerical Pain Scale (NPS) uses a 0-10 point rating system in which the patient selects the number that describes their current pain level, where "0" represents "no pain" and "10" represents "the worst pain imaginable"
Measured: Baseline, 4 weeks, 12 weeks
Knee Injury and Osteoarthritis Outcome score (KOOS)
The Knee Injury and Osteoarthritis Outcome is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start24 Jan 2025
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff P. Nadwodny, Mayo Clinic
- Investigators
- Jeffrey P Nadwodny, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782529
- Sponsor's protocol ID
- 24-005200
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Varying Doses of Steroid for Intra-articular Knee Injections
- ClinicalTrials.gov ID
- NCT06782529
- Acronym / sponsor ID
- 24-005200
- Conditions
- Osteoarthritis of Knee
- Keywords
- Knee Osteoarthritis, Corticosteroid Injection, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2027 (estimated)
- First posted
- 20 Jan 2025 (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.
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dose Group | Active comparator | Drug: Triamcinolone Acetonide Standard DosePatients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria. |
| Lower Dose Group | Experimental | Drug: Triamcinolone Acetonide Low DosePatients with knee osteoarthritis who are interested in knee intra-articular corticosteroid injections and meet the inclusion criteria. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with BMI ≥30 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.
Key exclusion criteria (4 listed)
- BMI < 30 kg/m2
- Uncontrolled diabetics with a hemoglobin A1c > 8%
- No other treatment within the time frame of the study.
- Patients that are undergoing physical therapy at the time of the study.
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 |
|---|---|---|
| Triamcinolone Acetonide Low DoseSubjects will receive a reduced dose of 20mg of triamcinolone acetonide. Total injection volume of 5ml, consisting of: * 0.5ml triamcinolone acetonide (20mg) * 4.5ml lidocaine (45mg) | Drug | Lower Dose Group |
| Triamcinolone Acetonide Standard DoseSubjects will receive the standard of care dose of 40mg triamcinolone acetonide Total injection volume of 5ml, consisting of: * 1ml triamcinolone acetonide (40mg) * 4ml lidocaine (40mg) | Drug | Standard Dose Group |
Primary outcome
Numerical Pain Scale (NPS)
Time frame: Baseline, 4 weeks, 12 weeks
The Numerical Pain Scale (NPS) uses a 0-10 point rating system in which the patient selects the number that describes their current pain level, where "0" represents "no pain" and "10" represents "the worst pain imaginable"
Knee Injury and Osteoarthritis Outcome score (KOOS)
Time frame: Baseline, 4 weeks, 12 weeks
The Knee Injury and Osteoarthritis Outcome is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Jeffrey P Nadwodny, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide Low Dose and Triamcinolone Acetonide Standard Dose in people with Osteoarthritis of Knee, run by Mayo Clinic 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey P Nadwodny, DO (904 953 6722, nadwodny.jeffrey@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale (NPS) (time frame: Baseline, 4 weeks, 12 weeks). 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 10 Mar 2026.