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

NCT04308213 | Unknown DMC

• 1 other identifier: 955
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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, 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

Keywords

arthritis; mesenchymal stem cells

Outcome Measures

Primary Outcomes (2)

• Change of the Constant-Murley score

  Constant-Murley score: is a scale of 100 points that defines the level of pain and the ability to perform normal daily activities of the patient. The test is divided into 4 subscales: pain (15 points), daily life activity (20 points), force (25 points), range of movement: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).

  Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months

• Change of the VAS pain score

  Visual analogue Scale (VAS): The patient is asked to quantify pain by indicating its intensity on an visual analog scale (0 no pain, 10 the worst pain).

  Timepoints: Screening, 3, 6, 12, 24, 36, and 48 months

Secondary Outcomes (5)

• Change of range of motion (ROM)

  Timepoints: screening, 6, 12, 24, 36 and 48 months

• clinical change based on the DASH scale (disability of the arm, shoulder and Hand)

  Timepoints: screening, 6, 12, 24, 36 and 48 months

• clinical change based on the , American Shoulder and Elbow Surgeons (ASES) score

  Timepoints: screening, 6, 12, 24, 36 and 48 months

• evaluation of shoulder MRI results

  12 and 24 months

• evaluation of shoulder X-ray (XR) results

  12, 24 and 48 months

Study Arms (1)

Bone Marrow aspirate

EXPERIMENTAL

All the patients enrolled in the study will be treated with the bone marrow aspirate obtained with the Bone Marrow Cellution Kit.

Device: Marrow Cellution System

Interventions

Marrow Cellution System DEVICE

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.

Bone Marrow aspirate

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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".

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Alessandro Castagna, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Castagna

CONTACT

+390282244663; alessandro.castagna@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: November 12, 2019
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)