A Prospective Randomized Double Blinded Controlled Trial of Non-Operative Management of TFCC Injuries
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Edna Rath
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Disability of the Army Shoulder Hand (DASH)
研究概览
简要总结
Platelet-rich Plasma (PRP) is formed when a patient's blood sample is concentrated by a commercially available centrifuge. The sample then contains a high concentration of growth factors and has been used for numerous indications in a number of joints. This process has not yet been proven for non-operative management of the Triangular FibroCartilage Complex (TFCC), which is a very commonly injured soft tissue structure in the wrist. This study seeks to determine the efficacy of PRP for TFCC injuries.
详细描述
Platelet-rich Plasma (PRP) therapy has recently been indicated in the treatment of joint pain, arthritis, tendonitis, and to augment surgical treatment has become increasingly common (Hsu) PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic. (Hsu) In addition to being safe, PRP is efficacious. PRP has been well-studied including 10 prospective randomized controlled trials proving the effectiveness of PRP for knee osteoarthritis alone. (Dai) Strong evidence has also been reported in support of PRP use for bone healing (Bibbo, Tsai) tendinopathy (Mishra, Peerbooms) cartilage healing (Mei-Dan), and for augmentation of both ligament reconstruction (Fallouh) and repair (Mazzocca). Furthermore, the use of PRP has been shown to be a more cost effective treatment as compared to traditional methods in both chronic wound management and tendonitis (Gosens, Dougherty) PRP has not been studied in the wrist. Ulnar-sided wrist pain, most commonly involving the Triangular fibrocartilage complex (TFCC) is both difficult to diagnosis and treat,(Kleinmann, Fulcher, Graham) The TFCC is a meniscal homologue which acts to stabilize the wrist and to dissipate compressive forces. Tears within this soft tissue structure are painful and heal slowly. (Palmer, Palmer). Immobilization, steroid injections, or surgical treatment are the mainstays of treatment. However, PRP has not been studied as a treatment modality.
The purpose of this analysis is to study the efficacy of PRP injection in the treatment of a TFCC tear.
The null hypothesis is that there is no difference between injection into the wrist of PRP and saline (placebo).
The investigators hypothesize that PRP will reduce pain as compared to placebo.
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Disability of the Army Shoulder Hand (DASH)
时间窗: 12 months post injection
SCALE: 0-100 (0 being a good result and 100 being complete disability)
次要结局
- Michigan Hand Outcome Questionnaire (MHOQ(Pre-injection, 2 weeks, 3 months)
- Single Assessment Numerical Evaluation (SANE)(Pre-injection, 2 weeks, 3 months, 6 months, 12 months)
- Mayo Wrist Score (Mayo)(Pre-injection, 2 weeks, 3 months, 6 months, 12 months)
- Pain Anxiety Symptom Scale (PASS)(Pre-injection, 2 weeks, 3 months)
研究者
Edna Rath
Human Protection Director
William Beaumont Army Medical Center