跳至主要内容
临床试验/NCT01510639
NCT01510639已完成3 期

Results of Subacromial Surgery; The Influence of Growth Factors (PDGF), Applied as Autologous Thrombocyte Concentrate, on Functional Recovery

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
73
试验地点
2
主要终点
Change in VAS pain

研究概览

简要总结

The purpose of this study is to test the hypothesis that the application of PRP leads to faster wound healing, less wound healing disorders, less pain and faster functional recovery after subacromial surgery.

详细描述

Subacromial surgery of the shoulder is performed often. It concerns space creating interventions (open and arthroscopic subacromial decompression) and rotator cuff surgery (open and arthroscopic). In this kind of surgery good wound healing and tissue recovery is of great importance to achieve optimal results. Wound healing disorders, pain and the formation of adhesions may negatively influence the postoperative course and lead to extended rehabilitation. This has an unfavourable influence on the personal well being of the patient and the possibility to return to labour. Especially in cuff surgery the course is strongly influenced by the healing of the attachment of the cuff to the bone. Besides the development of minimal invasive techniques, it's necessary to look for possibilities to decrease the morbidity of these procedures. Recent studies show that growth factors play a major role in wound healing. This concerns particularly TFG-B (transforming growth factor B) and PDGF (platelet derived growth factor) present in thrombocytes. They act as chemotactic agents for polymorphonuclear leucocytes, macrophages, fibroblasts and lymphocytes. Both growth factors stimulate the wound healing and cause improved angiogenesis and fibroplasia. They also play a role in wound retraction and remodelling. In animal-experimental models it is proved that the application of TGF-B and PDGF improves woundhealing and leads to better mechanical properties of the scar tissue. Faster and better wound healing and decreased development of adhesions after subacromial surgery can possibly be influenced favourably by using thrombocyte concentrate. In the treatment with autologous thrombocyte concentrate a thrombocyte rich concentrate is obtained by a centrifuging method (Gravitational Platelet System (GPS), Biomet, Warsaw USA) (platelet rich plasma or PRP), that can be applied in the operating field. The concentrate is harvest from the patients own blood, sampled during the procedure. At random the concentrated is applicated and both groups are compared postoperatively.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • Given informed consent
  • Clinical indication for Arthroscopic Sub-acromial decompression, i.e.: Painful arc, pain at abduction, positive Hawkinstest Insufficient clinical improvement after (at least) 6 months of conservative treatment or Clinical indication for a arthroscopic cuff repair of a MRI-proven treatable rotator cuff tear.

排除标准

  • Coagulopathy
  • Thrombocytopenia
  • Use of corticosteroids
  • Diabetics Mellitus
  • Omarthritis
  • AC-arthrosis
  • Cuff arthropathy
  • Neurological deficit at the ipsi-lateral extremity
  • (Wish for) Pregnancy
  • VAS <2 or VAS >9

结局指标

主要结局

Change in VAS pain

时间窗: 2 years

Change in painscore measured on a VAS scale

次要结局

  • Functional recovery(2 years)
  • The amount of patients that had adequate wound healing(2 years)
  • The amount of patient who were able to resume their work(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. N. Wolterbeek

Study Coordinator

St. Antonius Hospital

研究点 (2)

Loading locations...

相似试验