NCT03117608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2024

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

5.5 years

First QC Date

April 6, 2017

Last Update Submit

August 28, 2017

Conditions

Osteoarthritis, Knee

Keywords

OAaMATPRP

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • stability of the clinical improvement documented with International Knee Documentation Committee (IKDC) score

    Time Frame: 6, 24 months evaluation

  • stability of the clinical improvement documented with Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time Frame: 3,6, 12, 24 months evaluation

Study Arms (2)

AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)

EXPERIMENTAL

injection of aMAT obtained with Lipogems® technology.

Biological: injection of autologous micro-fragmented adipose tissue (aMAT)

platelet-rich plasma (PRP)

ACTIVE COMPARATOR

single injection of platelet-rich plasma

Biological: injection of Platelet-rich Plasma (PRP)

Interventions

injection of autologous micro-fragmented adipose tissue (aMAT)BIOLOGICAL

adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.

AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)
injection of Platelet-rich Plasma (PRP)BIOLOGICAL

injection of platelet-rich plasma

platelet-rich plasma (PRP)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Silvia Versari

    Lipogems International spa

    STUDY DIRECTOR

Central Study Contacts

Silvia Versari

CONTACT

+39 02 37072408silvia.versari@lipogems.eu

Marco Tiana

CONTACT

+39 02 37072408marco.tiana@lipogems.eu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 18, 2017

Study Start

February 24, 2017

Primary Completion

August 24, 2022

Study Completion

February 24, 2024

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

IT(1)