Health TrialsbyHealthPanel

Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

ConditionKnee Arthroplasty, Total
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSteadman Philippon Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Losartan

    Drug

    12.5 mg oral Losartan taken for 28 days total (4 week postoperative).

  • Placebo - Losartan

    Drug

    Losartan appearance-matched Prosolv EasyTab SP placebo. 12.5 mg oral tablet taken for 28 days total (4 week postoperative).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Losartan (investigational)Experimental treatment 1 intervention
Group B: Placebo (control)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 weeks post-op, and 3 months post-op
2

Knee Range of Motion

Reported as degree of knee Flexion/Extension

Time frame
Baseline, 6 weeks post-op, and 3 months post-op

Secondary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Occurrence of adverse events

Time frame
From date of study drug dosing until the end of the study, an average of 3.5 months
2

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.

Time frame
Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
3

Flow cytometry immunosenescent phenotyping assessment of peripheral blood mononuclear cells

Cell types measured via flow cytometry and analyzed via immunophenotype and senescent panels.

Time frame
Baseline, 10-17 days post-op, 6 weeks post-op, and 3 months post-op
4

Knee Extensor Isometric Strength Assessment

Assessed via handheld dynamometer and inclinometer containing a load cell that will digitally record the knee extension force.

Time frame
Baseline, and 3 months post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steadman Philippon Research Institute

Lead sponsor

Source ClinicalTrials.gov
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