Status:
COMPLETED
Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Knee Injuries
Cartilage Injury
Eligibility:
All Genders
18-65 years
Brief Summary
The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clini...
Eligibility Criteria
Inclusion
- informed consent
- patients treated with combined single-step procedure (scaffold and fBMA) for knee articular surface lesions, between January 2013 and December 2020
- symptomatic knee articular surface lesions (International cartilage repair society (ICRS) grades 3-4, size ≥ 1.5 cm2) unresponsive to conservative treatment,
- only mild concomitant osteoarthritis (Kellgren-Lawrence grades 1-2)
Exclusion
- patients that refuse to participate in the study
- non responders to the invitation to answer PROMs at the follow-up
- associated medical conditions (inflammatory, metabolic, neoplastic, etc.) that could directly handicap the musculoskeletal system or indirectly impact the quality of life
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06078072
Start Date
September 1 2022
End Date
October 31 2023
Last Update
November 30 2023
Active Locations (1)
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1
University medical centre Ljubljana
Ljubljana, Slovenia, 1000