Injection of Platelet Rich Plasma and Autologous Fat Into the Thumb Carpometacarpal Joint for the Evaluation Their Potential Filling Effect in Patients With Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Change in perception of pain sensation in the thumb saddle joint
研究概览
简要总结
Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up to 25% of postmenopausal women. There are currently various conservative and surgical methods available for treatment. If conservative treatment does not lead to freedom from pain, one of the surgical methods can be used, such as metacarpal extension osteotomy, trapeziectomy with or without ligamentoplasty, trapeziometacarpal arthrodesis, prosthesis implantation and various forms of interposition arthroplasty . Despite the high satisfaction rate of up to 95% after surgical treatment, the anatomy of the carpus is irreversibly destroyed . Apart from that, these operations are also associated with corresponding complications and post-operative immobilization of several weeks. Thus, a minimally invasive treatment method with a corresponding success rate would be of great advantage.
Hypothesis:
By infiltrating and filling the joint with Platelet-Rich Plasma (PRP), fat or a combination of both, the pain of rhizarthrosis can be reduced.
Aim of the study:
The aim of the announced doctoral thesis is to investigate the effect of PRP, lipofilling and its combination on arthroses of the thumb saddle joint after a single joint injection and to compare it with a control group.It is to be proven that PRP, fat and their combination lead to a different degree of pain relief compared to the control group due to the expansion of the joint space and the associated filling effect.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed Rhizarthrosis
排除标准
- •pregnancy and breastfeeding
- •no signed Informed Consent
结局指标
主要结局
Change in perception of pain sensation in the thumb saddle joint
时间窗: is measured 5 times, from screening visit to 3 months after intervention
assessed by VAS (Visual Analogue scale). The range goes from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Change in quality of life score, assessed by Questionnaire SF36(is measured 5 times, from screening visit to 3 months after intervention.)
- Change in Disabilities of Arm, Shoulder and Hand (DASH) Score(is measured 5 times, from screening visit to 3 months after intervention.)
- Change in movement in the thumb saddle joint.(is measured 5 times, from screening visit to 3 months after intervention.)
- Change in force in the thumb saddle joint.(is measured 5 times, from screening visit to 3 months after intervention.)
- Change in mobility of the thumb(is measured 5 times, from screening visit to 3 months after intervention.)
- Change in Michigan Hand Outcomes Questionnaire (MHQ)(is measured 5 times, from screening visit to 3 months after intervention.)