Status:
UNKNOWN
Treatment of Osteoarthritis With Autologous, Microfragmented Adipose Tissue.
Lead Sponsor:
Hvidovre University Hospital
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The study is a blinded, multicenter, randomized, controlled trial with participants individually randomized to one of two parallel groups: 1. The intervention group: Participants receive one intra ar...
Detailed Description
2 Study Objective To investigate if intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system affects the patient reported outcome in patients with o...
Eligibility Criteria
Inclusion
- 2 Inclusion criteria
- Age 18-70 years.
- Kellgren-Lawrence grade 2 - 3 in the tibiofemoral joint
- The patient must be expected to be able to attend follow up examinations
- The patient must be able to speak and understand Danish
- The patient must be able to give informed consent
- 3 Exclusion criteria
- Smoking (the patient must consent to being non-smoking 6 weeks pre and post the procedure)
- Varus or valgus malalignment of the knee \> 5 degrees
- Laxity of the MCL or LCL of 10 degrees or more compared to the opposite knee
- Knee instability and anterior-posterior laxity of 3mm or above
- Preceding open surgery to the knee or fracture in the proximal tibia or distal femur
- Extension deficit of the knee
- Kellgren-Lawrence grade 4 in any of the three compartments
- BMI \> 40
- Terminal illness or severe medical illness: ASA score higher than or equal to 3
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03771989
Start Date
January 1 2019
End Date
March 30 2024
Last Update
September 22 2023
Active Locations (1)
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1
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650