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Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis (LOOK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03527693
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriele Cattaneo, Spotorno Foundation

Study Description
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Brief Summary:
The study aims to evaluate the effects of a single intra-articular injection of micro-fragmented adipose tissue obtained with the Lipogems® system in patients affected by knee chondropathy. End-points were determined by evaluating the patients in terms of improvement in symptoms, functional recovery and radiographic appearance compared to baseline.

Condition or disease Intervention/treatment
Symptomatic Knee Osteoarthritis Device: Lipogems injection

Detailed Description:

Background: The social impact of degenerative diseases is steadily increasing, because of the continued rise in the mean age of the active population. Articular cartilage lesions are generally associated with disability and symptoms such as joint pain and reduced function, and remain a challenge for the orthopaedic surgeon. Several non-invasive solution have been proposed, but the results achieved to date are far from being completely satisfactory. Recently, new therapeutic approaches, such as the use of mesenchymal stem cells, have been developed. Among the many sources, the adipose tissue is nowadays considered one of the smartest, due to its abundance and easy access.

The aim of this retrospective study is to explore whether patients affected by symptomatic knee osteoarthritis treated with micro-fragmented adipose tissue associated with a chondral shaving procedure experience an improvement in symptoms and function.

Methods: Thirty-eight consecutive patients affected by symptomatic knee osteoarthritis were treated in 2015 with an arthroscopic procedure associated with an injection of autologous and micro-fragmented adipose tissue. Micro-fragmented adipose tissue was obtained using a minimal manipulation technique in a closed system. Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical examination. Safety of the procedure, recording type and incidence of any adverse event, was also assessed.

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Observational Study on the Treatment of Knee Chondral Lesions in Arthroscopy With Autologous and Micro-fragmented Adipose Tissue
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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Intervention Details:
  • Device: Lipogems injection
    Micro-fragmented adipose tissue (10 cc) was injected intra-articular after the arthroscopic procedure (shaving or shaving + meniscectomy).

Outcome Measures
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Primary Outcome Measures :
  1. Clinical improvement documented with KOOS (Knee Injury and Osteoarthritis Outcome Score). [ Time Frame: 12 months ]
    Change in one or more of the 5 KOOS sub-scales (worst 0 - best 100) from baseline evaluation to 12 months follow-up. A minimum of 10 points improvement is considered a clinically relevant change.


Secondary Outcome Measures :
  1. Incidence of treatment-related adverse events (AE) [ Time Frame: 12 months ]
    Safety of the procedure, documenting characteristics and incidence of AE.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is composed of consecutive patients affected by symptomatic knee chondropathy observed at the Orthopedic Unit of Santa Corona Hospital / Spotorno Foundation Pietra Ligure (SV) and all treated with Lipogems® between 01 January 2015 and 31 December 2015.
Criteria

Inclusion Criteria:

  • knee chondropathy grade > II (ICRS classification),
  • constant pain and failure of conservative treatments (physiokinesitherapy, corticosteroids, HA and/or PRP) for at least 12 months.

Exclusion Criteria:

  • immune-mediated (non-infectious) synovitis
  • OA Kellgren-Lawrence grade >3
  • axial defects >10°
  • metabolic disorders
  • BMI > 40
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527693


Sponsors and Collaborators
Spotorno Foundation
Investigators
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Principal Investigator: Gabriele Cattaneo, MD Spotorno Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gabriele Cattaneo, Doctor, Spotorno Foundation
ClinicalTrials.gov Identifier: NCT03527693    
Other Study ID Numbers: protocol n° 164REG2016
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gabriele Cattaneo, Spotorno Foundation:
Knee Chondropathy, Osteoarthritis, Micro-fragmented fat.
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases