Micro-fragmented Adipose Tissue Injection Associated With Arthroscopic Procedures in Patients With Knee Osteoarthritis
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Retrospective Observational Study on the Treatment of Knee Chondral Lesions in Arthroscopy With Autologous and Micro-fragmented Adipose Tissue
1 other identifier
observational
38
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedFirst Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedMay 22, 2018
May 1, 2018
12 months
April 27, 2018
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Incidence of treatment-related adverse events (AE)
12 months
Interventions
Micro-fragmented adipose tissue (10 cc) was injected intra-articular after the arthroscopic procedure (shaving or shaving + meniscectomy).
Eligibility Criteria
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.
You may qualify if:
- knee chondropathy grade \> II (ICRS classification),
- constant pain and failure of conservative treatments (physiokinesitherapy, corticosteroids, HA and/or PRP) for at least 12 months.
You may not qualify if:
- immune-mediated (non-infectious) synovitis
- OA Kellgren-Lawrence grade \>3
- axial defects \>10°
- metabolic disorders
- BMI \> 40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 29848328DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriele Cattaneo, MD
Spotorno Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 17, 2018
Study Start
January 1, 2015
Primary Completion
December 31, 2015
Study Completion
December 31, 2016
Last Updated
May 22, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share