Trial | NCT03117608  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    118
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.
Study Started
Feb 24
2017
Primary Completion
Aug 24
2022
Anticipated
Study Completion
Feb 24
2024
Anticipated
Last Update
Aug 29
2017

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.

Biological injection of Platelet-rich Plasma (PRP)

injection of platelet-rich plasma

AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT) Experimental

injection of aMAT obtained with Lipogems® technology.

platelet-rich plasma (PRP) Active Comparator

single injection of platelet-rich plasma

Criteria 

Inclusion Criteria

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

Exclusion Criteria

Patients incapable to understanding and will;
Patients participating in previous, concurrent or not, trials (ongoing or completed within three months);
Patients surgically treated for the same defect within one year;
Patients affected by malignancy;
Patients affected by metabolic or thyroid disorders;
Patients used to alcohol or drug (medication) abuse;
Patients affected by synovitis;
Varus or valgus misalignment exceeding 15°;
Body Mass Index > 40;
Patients with trauma within 6 months pre-operative.
No Results Posted