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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Biological: injection of autologous micro-fragmented adipose tissue (aMAT); Biological: injection of Platelet-rich Plasma (PRP)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Silvia Versari; Phone Number: +39 02 37072408; Email: silvia.versari@lipogems.eu
• Study Contact Backup: Name: Marco Tiana; Phone Number: +39 02 37072408; Email: marco.tiana@lipogems.eu

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Rizzoli Orthopaedic Institute
    • Contact: Maurilio Marcacci; Email: m.marcacci@biomec.ior.it
    • Contact: Giuseppe Filardo; Email: ortho@gfilardo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)	Time Frame: 24 months evaluation
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Lipogems International spa
• Investigators: Study Director: Silvia Versari, Lipogems International spa

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Anticipated): August 24, 2022
• Study Completion (Anticipated): February 24, 2024

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: OA; aMAT; PRP
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: LIPOJOINT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No