Status:
UNKNOWN
Subchondral and Intra-articular Application of Bone Marrow Concentrate for Knee Unicompartmental OA
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Osteoarthritis, Knee
Cartilage Degeneration
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
Unicompartmental knee osteoarthritis (OA) is a common finding especially in patients with lower limb malalignment and previous meniscectomy. Among the various treatment options, in recent years there ...
Eligibility Criteria
Inclusion
- chronic symptomatic (at least 6 months) medial or lateral unicompartmental OA of the knee, with Kellgren-Lawrence Score evaluated at x-rays= 2 or 3;
- MRI evidence of "bone marrow edema" affecting the subchondral bone of the tibial emiplateaux and femoral condyle;
- failure of previous conservative treatments in the same knee (e.g: pharmacological therapy, physiotherapy, previous intra-articular injections, etc..);
- willingness to participate in the trial, including all follow-up visits and radiographic examinations.
Exclusion
- medial or lateral unicompartmental OA with Kellgren-Lawrence score= 1 or 4 (i.e. early osteoarthritis or end-stage osteoarthritis);
- no MRI evidence of bone marrow edema in the affected knee compartment;
- concurrent rheumatic or other immunological diseases;
- concurrent malignancies;
- bilateral symptomatic knee OA;
- concurrent patello-femoral OA;
- BMI\>35
- any surgical treatment in the index knee within 12 months from the screening visit.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03790189
Start Date
January 1 2019
End Date
November 1 2021
Last Update
December 31 2018
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089