A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee (LIPOJOINT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03117608|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: injection of autologous micro-fragmented adipose tissue (aMAT) Biological: injection of Platelet-rich Plasma (PRP)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY OF A SINGLE, INTRA-ARTICULAR INJECTION OF AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) VERSUS (VS) PRP IN PATIENTS WITH OSTEOARTHRITIS (OA) OF THE KNEE|
|Actual Study Start Date :||February 24, 2017|
|Estimated Primary Completion Date :||August 24, 2022|
|Estimated Study Completion Date :||February 24, 2024|
Experimental: AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)
injection of aMAT obtained with Lipogems® technology.
Biological: injection of autologous micro-fragmented adipose tissue (aMAT)
adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.
Active Comparator: platelet-rich plasma (PRP)
single injection of platelet-rich plasma
Biological: injection of Platelet-rich Plasma (PRP)
injection of platelet-rich plasma
- Safety [ Time Frame: Time Frame: 24 months evaluation ]Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
- clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score) [ Time Frame: Time Frame: 6 months evaluation ]change in IKDC and KOOS score
- stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score [ Time Frame: Time Frame: 6, 24 months evaluation ]Change in IKDC Subjective score from baseline to follow up
- stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Time Frame: 3,6, 12, 24 months evaluation ]Change in KOOS score from baseline to follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117608
|Contact: Silvia Versari||+39 02 email@example.com|
|Contact: Marco Tiana||+39 02 firstname.lastname@example.org|
|Study Director:||Silvia Versari||Lipogems International spa|