Knee Arthroplasty, TotalPhase 1/2NCT06108063
Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
A Phase 1/2 study testing Losartan in people with Knee Arthroplasty, Total, run by Steadman Philippon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to 30 Jun 2027
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned primary total knee arthroplasty of a single knee;
- Male or female ≥ 18 years of age;
- Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.
Who cannot join
- Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
- Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
- Previous knee arthroplasty on the study knee;
- Previous infection affecting the study knee;
- Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
- Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
Show all 13Show fewer
- Planned lower extremity surgery (other than TKA in the study leg) for the duration of study participation;
- Any condition other than knee osteoarthritis that significantly impairs ability to walk or perform other activities of daily living;
- Currently taking: Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
- Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period);
- Allergic to any active or inactive ingredient of Losartan;
- Taking medication with known adverse Losartan interaction;
- Subjects that have any medical condition, including malignancies, laboratory findings, and/or findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects 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
The Steadman Clinic
Vail, Colorado, 81657
Suzanne L Page, JD, 970-401-8770, spage@sprivail.org
Luz Thede, 970-409-7566, lthede@sprivail.org
About this study
The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
Read the detailed description
This is a double-blind, randomized, placebo-controlled clinical trial proposed to evaluate the efficacy and safety of Losartan for reducing or preventing arthrofibrosis and improving patient-reported outcomes after total knee arthroplasty (TKA). Fibrosis will be evaluated over time after TKA using measures of knee range of motion and capsular thickening.
120 patients scheduled to undergo total knee arthroplasty will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC) and randomized into one of two arms (1:1).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Losartan, Placebo - Losartan
- Keywords
- TKA Losartan Arthrofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Losartan potassium
12.5 mg oral Losartan taken for 28 days total (4 week postoperative).
Placebo - LosartanDrug
Also called Placebo Oral Tablet
Losartan appearance-matched Prosolv EasyTab SP placebo. 12.5 mg oral tablet taken for 28 days total (4 week postoperative).
| Study group | Role | What they receive |
|---|---|---|
| Losartan (investigational) | Experimental | Losartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery). Receives: Drug: Losartan |
| Placebo (control) | Placebo comparator | Losartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery). Receives: Drug: Placebo - Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum
Thickness of knee joint capsule will be measured using quantitative ultrasound. The thickness will be measured using the distance between the two bright echoes seen on the ultrasound image that correspond to the superficial and deep edges of the capsule.
Measured: Baseline, 6 weeks post-op, and 3 months post-op
Knee Range of Motion
Reported as degree of knee Flexion/Extension
Measured: Baseline, 6 weeks post-op, and 3 months post-op
Secondary outcomes (7)
Incidence of Treatment-Emergent Adverse Events
Occurrence of adverse events
Measured: From date of study drug dosing until the end of the study, an average of 3.5 months
TGF-ß multiplex immunoassay assessment of peripheral blood plasma/serum
Biomarkers assessed will include quantifying secreted proteins related to inflammation, fibrosis, and senescence in the non-cellular fraction of the blood (e.g., serum and/or plasma) using commercially available immunocapture assays.
Measured: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells
Cell types measured via flow cytometry and analyzed via immunophenotype and senescent panels.
Measured: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Knee Extensor Isometric Strength Assessment
Assessed via handheld dynamometer and inclinometer containing a load cell that will digitally record the knee extension force.
Measured: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Knee Pain
Scale from 1-10. Higher score represents greater knee pain.
Measured: Baseline, day of surgery, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities
Scale from 0-96. Higher score represents worse knee health.
Measured: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Veteran's Rand 12-Item Health Survey
Includes two subscales to calculate the total score. Higher score represents greater health. Scale standardized to a US Population mean of 50 and standard deviation of 10 points.
Measured: Baseline, and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start6 Mar 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, double-blind, placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steadman Philippon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johnny Huard, PhD, Principal investigator, Steadman Philippon Research InstituteScott Tashman, PhD, Principal investigator, Steadman Philippon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108063
- Sponsor's protocol ID
- 2023-194
- Status last verified
- Mar 2024
- First submitted
- 23 Oct 2023
- Last updated
- 12 Mar 2024
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
- ClinicalTrials.gov ID
- NCT06108063
- Acronym / sponsor ID
- 2023-194
- Conditions
- Knee Arthroplasty, Total
- Keywords
- TKA Losartan Arthrofibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Steadman Philippon Research InstituteUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Oct 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.
The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
Detailed description
This is a double-blind, randomized, placebo-controlled clinical trial proposed to evaluate the efficacy and safety of Losartan for reducing or preventing arthrofibrosis and improving patient-reported outcomes after total knee arthroplasty (TKA). Fibrosis will be evaluated over time after TKA using measures of knee range of motion and capsular thickening.
120 patients scheduled to undergo total knee arthroplasty will be recruited from the clinical practice of the Principal Clinical Investigator or his designee at The Steadman Clinic (TSC) and randomized into one of two arms (1:1).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, double-blind, placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Losartan (investigational) | Experimental | Drug: LosartanLosartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery). |
| Placebo (control) | Placebo comparator | Drug: Placebo - LosartanLosartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned primary total knee arthroplasty of a single knee;
- Male or female ≥ 18 years of age;
- Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.
Key exclusion criteria (13 listed)
- Breastfeeding, pregnant, or planning to become pregnant during participation in the study;
- Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
- Previous knee arthroplasty on the study knee;
- Previous infection affecting the study knee;
- Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
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 |
|---|---|---|
| LosartanAlso: Losartan potassium12.5 mg oral Losartan taken for 28 days total (4 week postoperative). | Drug | Losartan (investigational) |
| Placebo - LosartanAlso: Placebo Oral TabletLosartan appearance-matched Prosolv EasyTab SP placebo. 12.5 mg oral tablet taken for 28 days total (4 week postoperative). | Drug | Placebo (control) |
Primary outcome
Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum
Time frame: Baseline, 6 weeks post-op, and 3 months post-op
Thickness of knee joint capsule will be measured using quantitative ultrasound. The thickness will be measured using the distance between the two bright echoes seen on the ultrasound image that correspond to the superficial and deep edges of the capsule.
Knee Range of Motion
Time frame: Baseline, 6 weeks post-op, and 3 months post-op
Reported as degree of knee Flexion/Extension
7 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: From date of study drug dosing until the end of the study, an average of 3.5 months
TGF-ß multiplex immunoassay assessment of peripheral blood plasma/serum
Time frame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells
Time frame: Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Knee Extensor Isometric Strength Assessment
Time frame: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Numeric Rating Scale for Knee Pain
Time frame: Baseline, day of surgery, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
Patient Reported Outcomes Questionnaire-Western Ontario and McMaster Universities
Time frame: Baseline, and 3 months post-op
Patient Reported Outcomes Questionnaire-Veteran's Rand 12-Item Health Survey
Time frame: Baseline, and 3 months post-op
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 12 Mar 2024.
- 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.
Johnny Huard, PhD principal investigator
Steadman Philippon Research Institute
Scott Tashman, PhD principal investigator
Steadman Philippon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Losartan in people with Knee Arthroplasty, Total, run by Steadman Philippon Research Institute 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 3 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: looking for participants now, as of the sponsor's last update on 12 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Suzanne L Page, JD (970-401-8770, spage@sprivail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Ultrasound Measurement of Capsular Thickness at Lateral Retinaculum (time frame: Baseline, 6 weeks post-op, and 3 months post-op). 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 12 Mar 2024.