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

Phase 4

• Conditions: Osteoarthritis, Knee
• Interventions: Biological: injection of Platelet-rich Plasma (PRP); Biological: injection of autologous micro-fragmented adipose tissue (aMAT)

• Registration Number: NCT03117608
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-02-24
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-28
• Last Update Posted: 2017-08-29
• Primary Completion: 2022-08-24
• Study Completion: 2024-02-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet-rich plasma (PRP)	injection of Platelet-rich Plasma (PRP)	single injection of platelet-rich plasma
AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)	injection of autologous micro-fragmented adipose tissue (aMAT)	injection of aMAT obtained with Lipogems® technology.

Primary Outcome Measures

Name	Time	Method
Safety	Time Frame: 24 months evaluation	Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)	Time Frame: 6 months evaluation	change in IKDC and KOOS score

Secondary Outcome Measures

Name	Time	Method
stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score	Time Frame: 6, 24 months evaluation	Change in IKDC Subjective score from baseline to follow up
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)	Time Frame: 3,6, 12, 24 months evaluation	Change in KOOS score from baseline to follow up

Trial Locations

Locations (1)

Rizzoli Orthopaedic Institute; 🇮🇹 Bologna, Italy