Performance of Autologous Platelet-rich Plasma Injection for Tendon Regeneration in Partial Supraspinatus Tears
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
The goal of this clinical trial is to learn whether platelet-rich plasma (PRP) injection, made from a participant's own blood, can help heal the tendon and improve shoulder symptoms in people with partial tears of the supraspinatus tendon.
The main questions it aims to answer are:
- Does PRP help the tendon heal?
- Does PRP improve pain, shoulder movement, daily function, and shoulder magnetic resonance imaging (MRI) findings?
Researchers will compare PRP plus standard of care (physical therapy) to standard of care alone to see if PRP leads to better healing and better clinical results. Researchers will also study if differences in specific biomolecules in PRP are associated with differences in treatment response.
Participants will:
- receive standard of care treatment, with or without PRP injection depending on the study group
- have blood collected for PRP preparation
- have their pain, shoulder movement, and shoulder function assessed
- undergo shoulder MRI scans
- be followed over time to measure healing and symptom improvement
详细描述
Purpose and rationale:
Rotator cuff injuries are common musculoskeletal injuries and among the most frequent causes of shoulder pain and disability. The mechanisms underlying tendon repair are complex and are promoted by local cell activation, cell migration and proliferation, pro- and anti-inflammatory cytokines and growth factors, extracellular matrix production and reorganization. Growth factors are a key element of tissue regeneration and healing, and several growth factors/cytokines have been applied in osteoarticular conditions, in both animal and human studies. Platelet-rich plasma (PRP) is a platelet concentrate produced from autologous blood sample manipulation that is abundant in growth factors and cytokines with potential regenerative capabilities. The role of PRP in several osteoarticular conditions has been established, but controversy remains in shoulder applications, with recent evidence of benefits in shoulder augmentation surgery for rotator cuff repair. Our study evaluates the performance of autologous PRP injection in partial rotator cuff tears for tendon regeneration as an adjuvant to the standard of care treatments, the relationship of PRP growth factor/cytokine content with clinical efficacy and imaging findings that may predict clinical decision-making, prognostication and treatment response.
Hypothesis and objectives The study hypothesis is that PRP promotes tendon regeneration and clinical improvement in participants with partial supraspinatus tears when added to standard rehabilitation care.
The primary objective is to evaluate the impact of PRP on tendon regeneration and clinical improvement in participants with partial supraspinatus tears, in addition to standard rehabilitation care.
Secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Physical therapists, radiologists and data collecting personnel will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients are at least 18 years old, and have clinical (VAS pain score ≥4, loss of >25% in ROM, positive in at least one clinical test such as Jobe, Neer, Drop arm, Hawins-Kennedy, Patte) and imaging findings compatible with partial supraspinatus tear, within 3 months of diagnosis.
- •Patients may have undergone conservative treatments, including lifestyle modification, oral analgesics, or physical therapy, with the exception of shoulder injections.
- •Must be willing to provide consent.
排除标准
- •Patients less than 18 years old
- •Patients with other or concomitant rotator cuff or shoulder muscle/tendon tear(s), complete tears, SLAP tears ≥ grade 2
- •Patients with auto-immune based joint diseases, osteoarthritis (KL grade ≥ 2), adhesive capsulitis, infection, nerve-related conditions, immunocompromised conditions, malignancy, coagulopathy
- •Patients on antiplatelet, anticoagulant, antitumor or immunosuppressive drugs
- •Uncontrolled diabetes, other systemic disorders (hepatitis, rheumatoid arthritis)
- •Pregnancy
- •Shoulder instability
- •Previous shoulder injection or surgery
- •Unwillingness to provide informed consent