Open-label trial of intra-articular injections of Hymovis nto the glenohumeral articular space for the treatment of chronic painful shoulder with limitation of motion due to glenohumeral joint osteoarthritis

Fidia Farmaceutici S.p.A.0 sites50 target enrollmentApril 17, 2015

Overview

No summary available.

Registry

who.int

Start Date

April 17, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional

Sex

All

Sponsor

Fidia Farmaceutici S.p.A.

•1\. Male or female aged 45 years or older
•2\. Patient with chronic shoulder pain (due to OA). Chronic shoulder pain is defined as follows:
•2\.1\. Persistence for a period of at least 6 months, but not greater than 5 years
•2\.2\. Perceived by the patient with a frequency of at least 50% of the days in the month preceding the inclusion visit
•3\. Kellgren\-Lawrence Grade 2 or 3 of glenohumeral joint confirmed by a X\-ray performed within 3 months from the inclusion visit
•4\. Evidence of glenohumeral concentricity
•5\. At baseline, pain during activity of the target shoulder measured by VAS presenting a score included between 40 and 80 mm
•6\. At baseline, VAS pain of the contralateral shoulder needs to be at least 10 mm less than the target joint and no more than 40 mm
•7\. At inclusion, patient with a limitation of shoulder motion in at least one direction for the following active range of motions:
•7\.1\. Abduction with scapula fixed must be \= 80°

•1\. Presence of adhesive capsulitis by clinical evaluation
•2\. Evidence of rotator cuff lesions
•3\. Presence of primary extra\-articular shoulder syndromes (e.g. impingement, bursitis, tendinitis)
•4\. Detection of clinically significant shoulder joint deformities
•5\. Shoulder X\-ray findings of acute fractures, severe loss of bone density and/or severe deformity
•6\. Diagnosis of Calcium Pyrophosphate Dihydrate Crystal Deposition Disease (CPPD) or Chondrocalcinosis of the shoulder
•7\. Presence of cervical spine disorder (that could confound the clinical assessment) that have been symptomatic and required active treatment within the past 3 months from inclusion
•8\. Presence of any active musculoskeletal disease that could confound the diagnosis/evaluation of the painful shoulder, or any neurological ethiology of the pain and any acute infection of the joint
•9\. Presence of any major surgery, arthroplasty or arthroscopy in the target shoulder within 6 months of inclusion/or planned surgery within the duration of the study
•10\. Patient in treatment with local radiotherapy for breast cancer