Impact of Autologous Platelet Rich Plasma on Enhancing Repair of Rotator Cuff Tendons: A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Visual Analogue Pain Scale
研究概览
简要总结
Partial-thickness and full-thickness rotator cuff tears are common soft-tissue conditions that often require surgical treatment. Initial efforts to improve tendon healing centered on improving the strength of the repair construct. More recent studies have focused on biologic enhancement of the healing process. The use of platelet concentrates to improve healing, has been explored considerably during the last decade. Platelet Rich Plasma (PRP) is a fraction of plasma that has been isolated and used to enhance regeneration in bone and soft tissues.
There is information on use of PRP in oral surgery, achilles tendon healing, limb lengthening procedures, chronic elbow tendinosis, ruptures/degenerative changes in the patellar tendon, and osteoarthritis of the knee. There are no randomized clinical trials to our knowledge that have examined the impact of PRP in patients with rotator cuff tear.
The objective of the proposed pilot study is to examine the effectiveness of autologous Platelet Rich Plasma (PRP) application in promoting healing of the rotator cuff (RC) tendons following arthroscopic rotator cuff repair through a randomized controlled study.
详细描述
Surgical procedures: Arthroscopic inspection of the shoulder will be performed to assess intra-articular structures and to evaluate the rotator cuff and other sub-acromial structures.
Arthroscopic Rotator Cuff Repair: Rotator cuff tears will be categorized as partial-thickness and full-thickness tears. The full-thickness tears will be classified as small (<1 cm), moderate (1-3 cm), and large (>3-5 cm) based on the largest dimension and will be treated with a repair using sutures and suture anchors as indicated.
Rehabilitation: A comprehensive protocol with instructions on different types of exercises will be provided pre-operatively. Rehabilitation will be based on the standard protocols for these procedures used at the Holland Centre.
Follow-ups: Patients will be monitored for 6 months, or when participation is terminated by the investigators, or because the patient withdrew consent or fails to return for visits. To evaluate safety, clinical laboratory (WBC, Hb, platelet count, serum chemistry and IL-6, CRP, PT, PTT and INR tests will be conducted at 6 weeks, and 3 months to determine the impact of treatment interventions.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Diagnosis of partial or full-thickness rotator cuff tear of less or equal to 3 cm. confirmed by MRI or US within a period of 6 months prior to booking surgery.
- •The final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology.
排除标准
- •Unable to speak or read English
- •Non-repairable tear
- •Acute tears (<6 month)
- •Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder
- •Concurrent pathology of Superior Labral Anterior and Posterior (SLAP) lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint
- •Previous surgery of the affected shoulder
- •Bone marrow pathology
- •Abnormal platelet count
- •Serum hemoglobin concentration <11 g/dL or hematocrit <34%
- •Use of systemic cortisone
- •Current use of anticoagulants (i.e. Aspirin)
- •Use of an investigational drug and/or blood donation within the previous 3 months prior to surgery
- •Substance or alcohol abuse
- •Heavy smoking [a daily cigarettes consumption of more than 20 pieces, based on definition of the World Health Organization (WHO)]
- •Psychiatric illness that precludes informed consent
研究组 & 干预措施
Platelet Rich Plasma
The platelet concentrate extracted from patient's own blood (PRP) will be applied to the surgical site after completion of the repair.
干预措施: Platelet Rich Plasma (Other)
Surgical repair (standard-of-care)
Patients will have a rotator cuff repair without the PRP application.
结局指标
主要结局
Visual Analogue Pain Scale
时间窗: The primary outcome will be collected pre and post-operatively. The level of pain and medication utilization will be monitored throughout the study by completing a pain diary (day 1-30) and at 6 weeks, 3 months and 6 months following surgery.
次要结局
- Adverse Effect(6 months)
- Patient- focused outcomes(Before surgery and 3 and 6 months following surgery)
- Magnetic resonance Imaging (MRI)(6 months after surgery)
研究者
Dr. Helen Razmjou
Research Associate
Sunnybrook Health Sciences Centre