Multicenter, open-label trial of intra-articular injections of HADD®4-G into the glenohumeral articular space for the treatment of chronic painful shoulder with limitation of motion due to glenohumeral joint osteoarthritis

Completed

• Conditions: Glenohumeral osteoarthritis; Musculoskeletal Diseases; Other specified arthrosis

• Registration Number: ISRCTN12525856
• Lead Sponsor: Fidia Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-17
• Last Update Posted: 6 July 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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°
7.2. Internal rotation in abduction must be = 55°
7.3. External rotation in abduction must be = 80°
These limitations of the shoulder are in comparison to normal expected ranges
8. Patient who failed to adequately respond to conservative non-pharmacologic therapy and simple analgesic intake
9. Willing and able to understand and sign an approved Informed Consent form
10. No pregnancy, nor breastfeeding. Females of childbearing potential (including those less than 1 year post-menopausal) must agree to maintain reliable birth control throughout the study

Exclusion Criteria

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
11. Patient with rheumatic polymyalgia
12. Prior history of any malignancy (with the exception of basal cell carcinoma) of the skin treated less than 2 years ago
13. Medical history of recurrent severe allergic or immune-mediated reactions
14. Presence of infections and/or skin diseases in the area of the injection site; psoriasis
15. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease that might interfere with the outcome of the study or the patient’s incapacity to comply with study requirements
16. Known or suspected allergic reactions to hyaluronate preparations or paracetamol
17. Assumption of i.a. HA products, within 1 month prior to the inclusion visit
18. Assumption of bisphosphonates, and/or oral pharmaceutical products containing glucosamine and/or chondroitin sulphate and/or diacerein (e.g., Chondrosulf, Structum 500, Dona, Viatril, Fisiodar, Artrodar etc.) within 1 month prior to the inclusion visit unless on a stable dose for at least 2 months at inclusion visit
19. i.a. corticosteroid injections to the target joint in the 3 months prior to inclusion visit
20. i.a. corticosteroid injections to any other joint in the month prior to inclusion visit
21. Assumption of oral corticosteroid in the month prior to the inclusion visit (inhalator corticosteroid is allowed only)
22. Prior use of HA in the target shoulder joint in the 6 months prior to inclusion
23. Changes in the physical therapy in the month preceding the inclusion visit or unwillingness to maintain stable regimen
24. Patient with history of thyroid insufficiency
25. Patient under treatment with anticoagulant drugs
26. Patient under treatment with phenobarbital prior to inclusion in the study
27. Assumption of analgesic drug (NSAIDs, opioid analgesics, topical analgesics) for any other condition that may interfere with the evaluation of the target shoulder
28. Assumption of any other 'investigational' product within 1 month prior to the inclusion visit
29. Patient who, in the judgement of the clinical investigator, are likely to be non-compliant or uncooperative during the study
30. Female who is pregnant or breastfeeding or not using recognised contraceptive measures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study objective in patients with chronic painful shoulder is to determine if two ultrasound-guided i.a. injections of Hymovis provide a significant reduction in pain during activity (using Visual Analogue Scale [VAS] 100 mm pain scale) up to 6 months from baseline in patient with OA of the shoulder (glenohumeral joint)<br>

Secondary Outcome Measures

Name	Time	Method
The secondary study objectives in patients with chronic painful shoulder due to OA are to determine if two ultrasound-guided i.a. injections of Hymovis:<br>1. Provide a reduction in pain perceived during the night up to 6 months from baseline <br>2. Provide an improvement of patient’s quality of life up to 6 months from baseline<br>3. Provide an improvement in shoulder functionality up to 6 months from baseline<br>4. Provide a reduction in rescue medication intake up to 6 months from baseline<br>5. Provide an improvement in patient’s status assessed by the physician (COGA) and the patient (PTGA) up to 6 months from baseline<br>6. Furthermore, as a secondary objective, the local and general safety of the treatment will be assessed <br>