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

Symptomatic Knee Osteoarthritis Clinical Trial

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Official title:

Retrospective Observational Study on the Treatment of Knee Chondral Lesions in Arthroscopy With Autologous and Micro-fragmented Adipose Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527693
• Other study ID #: protocol n° 164REG2016
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2018
• Source: Spotorno Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Symptomatic Knee Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spotorno Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement documented with KOOS (Knee Injury and Osteoarthritis Outcome Score).	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.	12 months
Secondary	Incidence of treatment-related adverse events (AE)	Safety of the procedure, documenting characteristics and incidence of AE.	12 months