Clinical trial NCT03117608: A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: OA
aMAT
PRP
Lead sponsor: Lipogems International spa
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety
timeFrame: Time Frame: 24 months evaluation
measure: clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: Time Frame: 6 months evaluation
Secondary outcomes:
measure: stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
timeFrame: Time Frame: 6, 24 months evaluation
measure: stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Time Frame: 3,6, 12, 24 months evaluation
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
affiliation: Lipogems International spa
name: Silvia Versari
role: STUDY_DIRECTOR
References: