ISRCTN10464365已完成不适用
A randomised controlled trial to assess the effectiveness of treating subacromial impingement and partial thickness rotator cuff tears wtih the administration of Platelet Rich Plasma during arthroscopic decompression surgery
niversity of Oxford (UK)0 个研究点目标入组 34 人开始时间: 2011年3月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with shoulder impingement syndrome or a partial thickness rotator cuff tear
- •2. Diagnosis confirmed using ultrasound scan by a trained member of the research team
- •3. Failed conservative treatment
- •4. Listed for arthroscopic subacromial decompression
- •5. Male or female, aged 35 - 75 years old
排除标准
- •1. Full thickness rotator cuff tears
- •2. Participants with a history of significant trauma (fracture, dislocation/instability, etc.), surgery, osteoarthritis or other significant pathology of the affected shoulder not related to the rotator cuff
- •3. Patient is unable to consent for themselves
- •4. No conservative treatment
- •5. Previous surgery on affected surgery
- •6. Contraindications to PRP (listed below):
- •6.1. History of diabetes mellitus
- •6.2. Platelet abnormality or platelets count less than 100 x 10^9/l
- •6.3. Haematological disorder
- •6.4. Serum haemoglobin less than 11 g/dl
- •6.5. Use of systemic cortisone
- •6.6. Use of any anticoagulant
- •6.7. Evidence of gangrene/ulcers or peripheral vascular disease
- •6.8. History of hepatic or renal impairment or dialysis
- •6.9. Patient is known to have a psychological, developmental, physical, emotional or social disorder that may interfere with compliance with study requirements
- •6.10. History of alcohol or drug abuse
- •6.11. Patient has a religious or cultural conflict with the use of platelet gel treatment or blood products
- •6.12. Patient has inadequate venous access for blood draw
- •6.13. Patient is currently receiving or has received radiation or chemotherapy within the last 3 months prior to the study
- •6.14. Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- •6.15. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
研究者
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