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NCT05660824
Effectiveness of Stromal Vascular Fraction (SVF) and Platelets Rich Plasma (PRP) in Osteoarthritis and Tendinopathy
Conditions: Tendinopathy, Osteoarthritis
Sex: All
Ages: 16 Years – N/A
Phase: PHASE4
Enrollment: 195
Sponsor: Adrien Schwitzguebel
Summary
In a multi-centric, randomized, triple-blind controlled trial, 195 patients will be separated in 2 subgroups: 130 individuals with osteoarthritis and 65 with tendinopathies.
The mian question to answer are the effect of SVF on :The clinical improvenentThe cartilage thickness evolution in case of osteoarthritisThe tendon healing in case of thendinopathyPatients will receive an initial single PRP or PRP + SVF injection followed by one- and two-months PRP doses.
In parallel, they will beneficiate of a proper rehabilitation plan with active physical therapies.
Eligibility Criteria
Inclusion Criteria:Informed Consent as documented by signature (Appendix Informed Consent Form)Age older than 16 years old,Symptomatic osteoarthritis of the hip, knee, ankle, elbow, shoulder confirmed by MRI or symptomatic tendinopathy confirmed by ultrasonography,Failure of first-line conservative management in the last 3 months including medical or infiltrative treatment, orthotics use, active rehabilitation plan, adaptation of sports and work habits.Exclusion Criteria:Patient is familiar with the lipoaspiration processIn case of tendinopathy: significant impingement according to investigator's judgementSubacromial impingement of the supraspinatus tendon, Haglund disease with erosion of the anterior part of Achilles tendonSignificant disease of the contralateral member with a function evaluated with SANE score below 80%In case of osteoarthritis: microcristalline disease (i.e.
gout, pseudogout),Active inflammatory rheumatic disorders,Need of regular anti-inflammatory treatment (either NSAIDs or corticosteroids),Allergy to local anesthetics or epinephrinBleeding disorders or current anticoagulation therapyPatients with decompensated renal failure, hepatic dysfunction, or severe pulmonary or cardiovascular disease,Patients with an immunocompromised statusWomen who are pregnant or intend to become pregnant during the studyInability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,Known or suspected non-compliance, drug, or alcohol abusePrevious enrollment into the current study,Participation in another study with investigational drug or procedure within the 30 days preceding and during the present studyEnrollment of the investigator, his/her family members, employees, and other dependent personsIf a bilateral disease is present and both sides require either the experimental or the control intervention, only the most symptomatic side will be studied.
Source: ClinicalTrials.gov (NCT05660824). StuddyBuddy aggregates publicly available trial information.