A Post-market, Randomized, Controlled, Clinical Investigation to Assess the Performance and Safety of HyalganBio® Intra-articular Injections, as add-on Physical Exercise Program, in the Symptomatic Relief of Glenohumeral Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
研究概览
简要总结
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. The main goal is to see whether patients improve shoulder function six months after the first injection, compared with patients who only follow the exercise program. Improvement is measured using the Constant-Murley Score (CMS).
Participants first attend a screening visit and, if they meet all criteria, they are enrolled. Within 14 days, they are randomly assigned to one of two groups: group 1 receives three weekly HyalganBio® injections and performs the PEP three times a week for 60 days, recording adherence in a diary; group 2: performs the same PEP schedule and also records adherence in a diary.
Follow-up visits take place at 2, 4, and 6 months after the first injection, with additional telephone check-ins at 1 and 3 months.
详细描述
This post-market, multicenter, randomized, controlled, open-label clinical investigation aims to evaluate the performance and safety of three intra-articular (IA) injections of HyalganBio® combined with a Physical Exercise Program (PEP) in patients with symptomatic glenohumeral osteoarthritis.
The primary objective is to assess the overall functional clinical improvement at 6 months after the first injection (V1), as measured by the Constant-Murley Score (CMS), comparing HyalganBio® + PEP versus PEP alone.
Eligible subjects are screened at Visit 0 (V0) after signing informed consent. If all inclusion and exclusion criteria are met, enrollment occurs and V0 may coincide with the baseline visit (V1). At V1, within 14 days from screening, participants are randomized 1:1. Group 1 receives three weekly IA injections of HyalganBio® (at V1, V2, V3) and is trained to perform a PEP three times per week for 60 days, recording adherence in a patient diary. Group 2 (control) is trained to perform the same PEP schedule and also reports adherence in a diary. Follow-up visits are planned at 2, 4, and 6 months after V1, with telephone contacts at 1 and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 45 years and ≤ 85 years.
- •Samilson Prieto Grade 1 to 3 of glenohumeral joint confirmed by a X-ray performed in the 6 months before the screening visit (or at the screening if not available in the past 6 months).
- •Patient suffering from glenohumeral arthrosis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
- •Patient who has persistent pain for a period of at least 6 months, but not exceeding 5 years; or
- •Pain perceived by the patient with a frequency of at least 50% of the days in the month preceding the screening visit.
- •Presence of pain on movement, in the target shoulder, measured by VAS with a score > 40 mm.
- •VAS for pain in the contralateral shoulder of at least 10 mm less than the target joint.
- •Willingness to discontinue oral and topical analgesics including NSAIDs if taken before study inclusion except for assumption of rescue medication (paracetamol) at a maximum dose of 6 tablets of 500 mg a day.
- •Patient willing to sign and able to understand the Informed Consent form.
- •If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable method of contraception throughout the investigation*.
- •Note: To be considered of non-childbearing potential, females must be surgically sterile or postmenopausal for at least 1 year.
- •*Highly effective birth control methods include: combined hormonal contraception (containing estrogen and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
排除标准
- •Presence, at clinical evaluation, of adhesive capsulitis.
- •Presence of rotator cuff injury (Massive Rotator Cuff Tears).
- •Signs, evident on X-ray of the shoulder, of recent fractures, intense loss of bone density and/or severe deformity.
- •Diagnosis of major calcium pyrophosphate dihydrate crystal deposition (CPPD) or shoulder chondrocalcinosis disease.
- •Presence of pathology of the cervical vertebrae (capable of altering the clinical evaluation) which, in the three months preceding the screening visit, was symptomatic and required active treatment.
- •Presence of any active musculoskeletal disease capable of altering the diagnosis/assessment of the shoulder with pain or presence of pain of any neurological aetiology and acute shoulder infection.
- •Presence of major surgery in arthroscopy in the shoulder under investigation in the 6 months prior to the screening and/or need to plan it.
- •Patient undergoing local radiotherapy for breast cancer.
- •Patient with rheumatic polymyalgia.
- •Patient with diabetes (Type 1 and Type 2 insulin-dependent).
- •Active skin cancer (except basal cell carcinoma) or history of skin cancer in the past two years.
- •Presence of infection and/or skin pathologies in the injection area.
- •Presence of severe gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological, immunological or other pathologies that can interfere with the results of the investigation or inability of the patient to comply with the requirements of the investigation.
- •Known allergy or suspected allergic reaction to hyaluronate.
- •Pharmaceutical products taken orally and containing glucosamine and/or chondroitin sulfate and/or diacerin (eg. Chondrosulf, Structum 500, Dona, Viatril, Fisiodar, Artrodar etc.) in the month prior to the screening visit, unless the dosage was stable for the two months prior to the screening visit.
- •Intra-articular corticosteroid injections into the shoulder under investigation in the three months prior to the screening visit.
- •Taking oral corticosteroids in the month prior to the screening visit (only inhaled corticosteroids are allowed and chronic oral therapies with daily intake below 7,5 mg).
- •Subjects with a history of chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from GH OA.
- •Previous use of HA in the shoulder under investigation in the 6 months prior to the screening visit.
研究组 & 干预措施
Physical Exercise Program (PEP)
Physical exercise program (PEP) for 3 days a week for a period of 60 days.
HyalganBio® plus Physical Exercise Program (PEP)
3 weekly intrarticular injections of HyalganBio® hyaluronic acid 20 mg/2 mL, supplied as a pre-filled syringe plus Physical exercise program (PEP) for 3 days a week for a period of 60 days.
干预措施: Hyaluronic acid plus Physical Exercise Program (PEP) (Device)
结局指标
主要结局
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
时间窗: 6 months from baseline.
The primary outcome of the investigation is the change of the total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
次要结局
- Clinical functional assessment on movement.(2, 4 and 6 months from baseline.)
- Clinical functional assessment on movement.(2 and 4 months from baseline.)
- Pain reduction(2, 4 and 6 months from baseline.)
- Changes of physical function(2, 4 and 6 months compared to baseline.)
- Changes of patient's quality of life.(2, 4 and 6 months compared to baseline (V1).)
- Rescue medication consumption(From baseline to the end of the study at 6 months.)
- Changes of Clinical Observer Global Assessment (COGA)(2, 4 and 6 months compared to baseline)
- Number of Participants with treatment-emergent adverse events.(From baseline to the end of the study at 6 months.)