Status:
UNKNOWN
Study on Shoulder Arthritis Treatment With Intra-articular Injections of Autologous Bone Marrow Aspirate.
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Shoulder Arthritis
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
Treatment of isolated osteoarthritis of the glenohumeral joint at the initial stages involves the use of numerous conservative or arthroscopic treatments with uncertain results and, upon their failure...
Detailed Description
Glenohumeral arthritis is one of the main reasons for persistent shoulder pain and reduced movement (range of motion, ROM) as it can compromise the work activity and also the normal daily activities, ...
Eligibility Criteria
Inclusion
- Male or female patients aged between 35 and 75.
- Light or moderate glenohumeral arthritis assessed by MRI.
- Failure after at least 6 months of conservative treatment (patients not responding to drug therapy with NSAIDs and pain killers, no benefit from hydro-kinesitherapy or physiotherapy, no benefit after a course of hyaluronic acid or PRP infiltrations, or after at least one corticosteroid infiltration)
- Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
- The signing of informed consent.
Exclusion
- Patients incapable of understanding and will
- Patients with shoulder trauma within 6 months prior to surgery
- Patients with malignancies;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with metabolic thyroid disorders;
- Patients abusing alcoholic beverages, drugs or drugs;
- Patients with signs of rotator cuff or long head biceps disease at MRI
- Patients with a history of untreated shoulder instability.
- Patients with arthroscopic evidence of rotator cuff injuries.
- Glenohumeral arthrosis "bone to bone".
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04308213
Start Date
November 12 2019
End Date
September 30 2024
Last Update
March 17 2020
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Milano, Italy, 20089