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Study on Shoulder Arthritis Treatment With Intra-articular Injections of Autologous Bone Marrow Aspirate.

NCT04308213 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-17

No results posted yet for this study

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, the current solution for the resolution of symptoms is shoulder arthroplasty, an effective procedure but with significant costs and rates of morbidity, especially in young patients. Since the use of intra-articular injections of mesenchymal cells obtained from the bone marrow has proved effective in the treatment of gonarthrosis, our goal is to evaluate the effectiveness of the same therapy in the treatment of glenohumeral arthritis isolated.

Conditions

  • Shoulder Arthritis

Interventions

DEVICE

Marrow Cellution System

The treatment will be carried out in the operating room under ordinary hospitalization and provides the intra-articular application of 9 ml of autologous bone marrow aspirate in the glenohumeral joint affected by arthrosis. To obtain the necessary amount, a bone marrow aspirate of about 12 ml will be taken from the iliac crest by means of the Marrow Cellution System, Geistlich Italia. This autologous bone marrow aspirate will be injected using the same syringe into the glenohumeral joint affected by arthrosis under amplioscopic control.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Alessandro Castagna, MD · Istituto Clinico Humanitas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2024-04-30
Completion
2024-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308213 on ClinicalTrials.gov