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

Osteoarthritis, Knee Clinical Trial

— LIPOJOINT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03117608
• Other study ID #: LIPOJOINT
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2017
• Last updated: August 28, 2017
• Start date: February 24, 2017
• Est. completion date: February 24, 2024

Study information

• Verified date: August 2017
• Source: Lipogems International spa
• Contact: Silvia Versari
• Phone: +39 02 37072408
• Email: silvia.versari[@]lipogems.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: February 24, 2024
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• injection of Platelet-rich Plasma (PRP)
injection of platelet-rich plasma

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Lipogems International spa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)	Time Frame: 24 months evaluation
Primary	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: 6 months evaluation
Secondary	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: 6, 24 months evaluation
Secondary	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: 3,6, 12, 24 months evaluation