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A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee (LIPOJOINT)

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ClinicalTrials.gov Identifier: NCT03117608
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Marcacci, Lipogems International spa

Brief Summary:
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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety [ Time Frame: Time Frame: 24 months evaluation ]
    Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Patients provided written informed consent;
  2. Patients aged between 18 and 75 years;
  3. Knee symptomatic OA (Kellgren-Lawrence grade 1-4)
  4. Failure of conservative treatment for at least 3 months;
  5. Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
  6. Male or female patients;
  7. Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.

Exclusion Criteria

  1. Patients incapable to understanding and will;
  2. Patients participating in previous, concurrent or not, trials (ongoing or completed within three months);
  3. Patients surgically treated for the same defect within one year;
  4. Patients affected by malignancy;
  5. Patients affected by metabolic or thyroid disorders;
  6. Patients used to alcohol or drug (medication) abuse;
  7. Patients affected by synovitis;
  8. Varus or valgus misalignment exceeding 15°;
  9. Body Mass Index > 40;
  10. Patients with trauma within 6 months pre-operative.

Information from the National Library of Medicine

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


Contacts
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Contact: Silvia Versari +39 02 37072408 silvia.versari@lipogems.eu
Contact: Marco Tiana +39 02 37072408 marco.tiana@lipogems.eu

Locations
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Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Contact: Maurilio Marcacci       m.marcacci@biomec.ior.it   
Contact: Giuseppe Filardo       ortho@gfilardo.com   
Sponsors and Collaborators
Lipogems International spa
Investigators
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Study Director: Silvia Versari Lipogems International spa
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Responsible Party: Prof. Marcacci, Principal Investigator, Lipogems International spa
ClinicalTrials.gov Identifier: NCT03117608    
Other Study ID Numbers: LIPOJOINT
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Marcacci, Lipogems International spa:
OA
aMAT
PRP
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases