Clinical trial NCT03527693: Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis
Official title: Retrospective Observational Study on the Treatment of Knee Chondral Lesions in Arthroscopy With Autologous and Micro-fragmented Adipose Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Knee Osteoarthritis
Keywords: Knee Chondropathy, Osteoarthritis, Micro-fragmented fat.
Lead sponsor: Spotorno Foundation
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical improvement documented with KOOS (Knee Injury and Osteoarthritis Outcome Score).
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of treatment-related adverse events (AE)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Spotorno Foundation
name: Gabriele Cattaneo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cattaneo G, De Caro A, Napoli F, Chiapale D, Trada P, Camera A. Micro-fragmented adipose tissue injection associated with arthroscopic procedures in patients with symptomatic knee osteoarthritis. BMC Musculoskelet Disord. 2018 May 30;19(1):176. doi: 10.1186/s12891-018-2105-8.