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

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
injection of autologous micro-fragmented adipose tissue (aMAT)
injection of Platelet-rich Plasma (PRP)
Sponsored by
Lipogems International spa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring OA, aMAT, PRP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rizzoli Orthopaedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)

platelet-rich plasma (PRP)

Arm Description

injection of aMAT obtained with Lipogems® technology.

single injection of platelet-rich plasma

Outcomes

Primary Outcome Measures

Safety
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)
change in IKDC and KOOS score

Secondary Outcome Measures

stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
Change in IKDC Subjective score from baseline to follow up
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Change in KOOS score from baseline to follow up

Full Information

First Posted
April 6, 2017
Last Updated
August 28, 2017
Sponsor
Lipogems International spa
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1. Study Identification

Unique Protocol Identification Number
NCT03117608
Brief Title
A Single Intra-articular Injection of aMAT vs PRP in Patients With OA of the Knee
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
August 24, 2022 (Anticipated)
Study Completion Date
February 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lipogems International spa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
OA, aMAT, PRP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)
Arm Type
Experimental
Arm Description
injection of aMAT obtained with Lipogems® technology.
Arm Title
platelet-rich plasma (PRP)
Arm Type
Active Comparator
Arm Description
single injection of platelet-rich plasma
Intervention Type
Biological
Intervention Name(s)
injection of autologous micro-fragmented adipose tissue (aMAT)
Intervention Description
adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.
Intervention Type
Biological
Intervention Name(s)
injection of Platelet-rich Plasma (PRP)
Intervention Description
injection of platelet-rich plasma
Primary Outcome Measure Information:
Title
Safety
Description
Safety of the procedure, documenting characteristics and incidence of adverse events.(AE)
Time Frame
Time Frame: 24 months evaluation
Title
clinical improvement documented with IKDC(International Knee Documentation Committee) score and KOOS (Knee Injury and Osteoarthritis Outcome Score)
Description
change in IKDC and KOOS score
Time Frame
Time Frame: 6 months evaluation
Secondary Outcome Measure Information:
Title
stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score
Description
Change in IKDC Subjective score from baseline to follow up
Time Frame
Time Frame: 6, 24 months evaluation
Title
stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Change in KOOS score from baseline to follow up
Time Frame
Time Frame: 3,6, 12, 24 months evaluation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Versari
Phone
+39 02 37072408
Email
silvia.versari@lipogems.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marco Tiana
Phone
+39 02 37072408
Email
marco.tiana@lipogems.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Versari
Organizational Affiliation
Lipogems International spa
Official's Role
Study Director
Facility Information:
Facility Name
Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurilio Marcacci
Email
m.marcacci@biomec.ior.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Filardo
Email
ortho@gfilardo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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