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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2024-02-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

NCT04901273

Knee Osteoarthritis

RECRUITING NA

Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial

NCT02923700

Osteoarthritis

COMPLETED PHASE4

Microfragmented Adipose Tissue Versus Platelet-rich Plasma for Knee Osteoarthritis: a Randomized Comparative Trial

NCT04351087

Osteoarthritis, Knee Microfragmented Adipose Tissue Platelet-Rich Plasma

COMPLETED NA

Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods

NCT04321629

Osteo Arthritis Knee Knee Osteoarthritis Knee Pain Chronic +4 more

UNKNOWN PHASE2

Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis

NCT05497349

Hip Osteoarthritis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AUTOLOGOUS MICRO-FRAGMENTED ADIPOSE TISSUE (aMAT)

injection of aMAT obtained with Lipogems® technology.

Group Type EXPERIMENTAL

injection of autologous micro-fragmented adipose tissue (aMAT)

Intervention Type BIOLOGICAL

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

platelet-rich plasma (PRP)

single injection of platelet-rich plasma

Group Type ACTIVE_COMPARATOR

injection of Platelet-rich Plasma (PRP)

Intervention Type BIOLOGICAL

injection of platelet-rich plasma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

injection of Platelet-rich Plasma (PRP)

injection of platelet-rich plasma

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes