A Phase 4 interventional study of injection of autologous micro-fragmented adipose tissue (aMAT) and injection of Platelet-rich Plasma (PRP) in Osteoarthritis, Knee, sponsored by Lipogems International spa. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Lipogems International spa · Phase 4, Interventional, and Treatment
The study proposes to compare performances and safety of intra-articular injections of aMAT with those of a control group (PRP injections) for the treatment of symptomatic OA of the knee. The end-points will be determined evaluating the performances of the treatment group in terms of improvement of the symptomatology, functional recovery and radiological appearance.
The clinical trial is a prospective, randomized, controlled, two-arm, single-blind study, involving 118 patients affected by symptomatic OA of the knee joint. Eligible subjects will be randomly allocated to one of the two treatment groups, with a 1:1 randomization ratio. Respectively, 59 patients treated with a single intra-articular injection of aMAT, and 59 patients treated with a single intra-articular injection of PRP.
The patients enrolled in the study will be treated according to the study protocol and followed after treatment with periodic visits and diagnostic imaging examinations, as Magnetic Resonance Imaging at twelve and twenty-four months follow-up and X-Ray, at three, six, twelve, and twenty-four months of follow-up.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 118 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Lipogems International spa is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria
injection of aMAT obtained with Lipogems® technology.
Biological: injection of autologous micro-fragmented adipose tissue (aMAT)
single injection of platelet-rich plasma
Biological: injection of Platelet-rich Plasma (PRP)
adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.
injection of platelet-rich plasma
Safety
Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
Time frame: Time Frame: 24 months evaluation
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
change in IKDC and KOOS score
Time frame: Time Frame: 6 months evaluation
stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
Change in IKDC Subjective score from baseline to follow up
Time frame: Time Frame: 6, 24 months evaluation
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS score from baseline to follow up
Time frame: Time Frame: 3,6, 12, 24 months evaluation
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Lipogems International spa