Does Autologous Conditioned Plasma Enhance Rotator Cuff Tendon Healing After Surgery? A Radomized Control Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in magnetic resonance imaging (MRI) score over time
研究概览
简要总结
The aim of this study is to establish if the application of autologous conditioned plasma (ACP), also described as platelet rich plasma (PRP), to the site of supraspinatus tendon repair beginning within two weeks of surgery, can improve patient outcomes over the course of 12 months. These outcomes will be measured by post-surgical pain and function scores, shoulder strength and range of motion (ROM), and radiological parameters of tendon healing. Outcome measures will be compared to a control group of patients receiving placebo injections following surgery (saline plus local anaesthetic).
This study is significant for being the first double blind randomised control trial, using two PRP injections to examine the efficacy of a PRP preparation following surgical repair of supraspinatus tendon. The objective is to prolong and enhance the tendon healing response initiated by surgery.
The research hypothesis is that enhanced tendon healing following the PRP injections will lead to more rapid rehabilitation and lower rates of re-rupture of the repaired tendon compared to the control group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50-75 years;
- •In a non-dependent relationship;
- •Full-thickness supraspinatus tendon tear (deemed repairable);
- •Pre-operative platelet count greater than 150 000.
排除标准
- •Previous rotator cuff repair surgery;
- •Active/distal infection;
- •Metabolic bone or blood disorders;
- •Pre-existing conditions associated with upper extremity pain;
- •Rotator cuff tears secondary to fracture;
- •Prior ACP/PRP injections;
- •Non-surgical rotator cuff treatment in the past month, including corticosteroids and anti-inflammatory treatment.
研究组 & 干预措施
Autologous conditioned plasma (ACP)
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The red blood cells will be discarded, and the supernatant containing ACP (with additional CaCl to activate the ACP and local anaesthetic) is injected into the tendon bone junction and adjacent area under ultrasound guidance. No adverse consequences are anticipated by using the Arthrex ACP injection.
- First injection at approximately 10 days post-operatively
- Second Injection at approximately 21 days post-operatively
Other Names:
Platelet rich plasma (PRP)
干预措施: Autologous conditioned plasma (ACP) (Other)
Placebo
10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound.
- First injection at approximately 10 days post-operatively
- Second Injection at approximately 21 days post-operatively
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in magnetic resonance imaging (MRI) score over time
时间窗: Pre-operatively, and 12 months post-operatively
MRI will assess the dimensions of the supraspinatus tear pre-operatively. MRI will assess the tendon healing of the supraspinatus tendon post-operatively at 12 months
次要结局
- Changes in the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire over time(Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in the Oxford Shoulder Score (OSS) over time(Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in shoulder range of motion over time(pre-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in the Simple Shoulder Test (SST) over time(Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in the visual analogue scale (VAS) for pain over time(Pre-operatively, 1st injection post-operatively, 2nd injection post-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in the Short Form - 12 health questionnaire (SF-12) over time(Pre-operatively, 6 weeks post-operatively, 12 weeks post-operatively, 6 months post-operatively, 12 months post-operatively)
- Changes in strength of the shoulder musculature over time(6 months post-operatively, 12 months post-operatively)
研究者
Allan Wang
Clinical Professor of Orthopaedic Surgery
The University of Western Australia