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临床试验/NCT07456215
NCT07456215已完成1 期

The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12月23日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Movin score

研究概览

简要总结

The aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear.

详细描述

The refractory to conservative treatment rotator cuff tears are mainly treated with arthroscopic repair. Intraoperative or postoperative platelet rich plasma (PRP) injections have been widely used to enhance the tendon healing and the repair process. Additionally, subacromial PRP injections are related to favorable outcomes in case of partial rotator cuff tears even one month after their application. Laboratory and clinical trials have correlated PRP with an increase in tenocyte metabolic activity, based on the up- or downregulation of specific gene expression.

Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.

The included patients will undergo an ultrasound-assisted PRP or saline subacromial injection, four to six weeks prior to the scheduled surgery. During the arthroscopic rotator cuff repair procedure, a tendon biopsy will be performed and the sample will be sent for further analysis.

The samples will be sent for histologic analysis and quantification of specific gene expression. The gene analysis will contain the collagen I, collagen III, metalloproteinase 3 and metalloproteinase 13 genes, which are related to tendon repair and remodeling in cases of rupture and/or injury. Furthermore, the two groups will be compared in terms of the MRI imaging findings. After statistical analysis, a conclusion regarding the effect of PRP on the enhancement of biological properties of the ruptured tendon and, consecutively, tendon healing process will be extracted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Full thickness rotator cuff tear treated with arthroscopic repair
  • Age of 18 to 65 years
  • Chronic shoulder pain due to rotator cuff tear
  • Magnetic resonance imaging study within 6 months prior to arthroscopy
  • Goutallier grade 1 or 2 muscle fatty infiltration

排除标准

  • Comorbidities, including coagulopathy, liver disease, cancer, nutritional disorder
  • Goutallier grade 3 or 4 muscle fatty infiltration
  • Shoulder osteoarthritis, rotator cuff arthropathy, rheumatoid arthritis
  • History oof shoulder injection within the last 12 months
  • History of prior shoulder surgery

研究组 & 干预措施

PRP group

Experimental

The experimental group includes patients to whom the PRP intervention will be applied.

干预措施: Platelet Rich Plasma (Biological)

Control group

Placebo Comparator

The control group includes patients to whom a normal saline injection will be applied.

干预措施: Normal saline (Other)

结局指标

主要结局

Movin score

时间窗: Immediately after surgery.

The Movin score qualifies the characteristics of tendon structure, including : fiber arrangement, fiber structure, rounding of the nuclei, inflammation, angiogenesis and cell density. The scores of the experimental and control groups will be compared.

次要结局

  • Bonar score(Immediately after surgery.)
  • Collagen I gene expression(Immediately after surgery.)
  • Collagen II expression(Immediately after surgery.)
  • Collagen III gene expression(Immediately after surgery.)
  • Metalloproteinase 3 gene expression(Immediately after surgery.)
  • Metalloproteinase 13 gene expression(Immediately after surgery.)
  • Interleukin 1β gene expression(Immediately after surgery.)
  • Interleukin 6 gene expression(Immediately after surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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