Platelet-rich Plasma for Thumb Carpometacarpal Joint Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The purpose of this study is to investigate a case series of patients treated with Platelet-rich plasma for thumb carpometacarpal joint osteoarthritis. Carpometacarpal arthritis is a highly prevalent condition with significant effects on quality of life and function. Meanwhile, platelet-rich plasma has been demonstrated to be an effective treatment for various musculoskeletal conditions.
详细描述
The first carpometacarpal (CMC) joint at the base of the thumb is one of the most commonly affected joints by osteoarthritis (OA), with a prevalence ranging from 15-36% in females and 5-11% in males. It is also functionally debilitating, with symptoms including diminished range of motion, weakness, deformity, instability, and pain. Despite the prevalence of first CMC OA, as well as the emerging evidence of platelet-rich plasma (PRP) efficacy for various musculoskeletal conditions, there is a paucity of studies investigating the two. To our knowledge, there are three studies in the literature, resulting in a total of 27 patients with first CMC OA receiving PRP to date1.
Common nonsurgical treatment options for management of this condition include oral and topical NSAIDs, hand therapy, activity modifications, splinting and intra-articular injections. Injections have traditionally consisted of corticosteroids demonstrating variable efficacy and viscosupplementation resulting in conflicting results. Surgical options include trapeziectomy with ligament reconstruction and tendon interposition, fusion, and less commonly, implant arthroplasty.
PRP is defined as an autologous, concentrated mix of platelets and inflammatory mediators suspended in plasma, obtained by centrifuging a patient's whole blood. It is hypothesized that PRP stimulates recruitment, proliferation, and differentiation of regenerative cells via release of various growth factors such as platelet-derived growth factor-AB and -BB, transforming growth factor-β1, insulin-like growth factor-1, fibroblast growth factor-basic, epidermal growth factor, vascular endothelial growth factor, and interleukin (IL)-12. The platelets in PRP have anti-inflammatory properties with modulators including IL-1 receptor antagonist, soluble tumor necrosis factor receptor I and II, IL-4, IL-10, IL-13 and interferon γ. Although PRP has been used for numerous musculoskeletal conditions, varying methods of extraction, different types of PRP, and lack of standardized reporting on the detailed biologic makeup of PRP has caused difficulties with interpretation and comparison of studies investigating its use. For these reasons, there has been a call for the standardization of PRP in clinical use.
The primary aim of this study was to assess (1) outcomes of PRP injection among patients with first CMC OA, and (2) the biologic characteristics of PRP injectate. The secondary aims were to describe the injection technique used at our institution and analyze the relationships between patient demographics, PRP biologic characteristics, and patient outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who previously underwent PRP injection of their first CMC joint.
排除标准
- •Individuals less than 18 years of age.
结局指标
主要结局
Patient satisfaction
时间窗: up to 12 months
Subjective patient satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best. Obtained via follow-up interview.
Patient symptom improvement
时间窗: up to 12 months
Subjective symptom satisfaction on a 1-5 point scale with 1 being the worst, 5 being the best. Obtained via follow-up interview.
Visual analogue pain scale
时间窗: up to 12 months
Subjective pain rating on a scale of 1-10 with 1 being no pain and 10 being severe pain. Obtained via automatically-generated follow-up questionnaire through electronic medical record. Obtained via follow-up interview.
Follow-up procedures/surgeries/interventions
时间窗: up 12 months
Patient described any required procedures/surgeries/interventions
Biologic characteristics of the whole blood and platelet-rich plasma included platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, and monocytes
时间窗: Day of procedure (within 24 hours of procedure)
Platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, and monocytes were measured in whole blood and platelet-rich plasma. These were reported in concentration of 10\^9/milliliter. There is little data regarding these expected values of platelet rich plasma and these are known to vary widely. Obtained through quality control analysis which was sent to pathology lab the day of procedure.
次要结局
未报告次要终点
研究者
Jeffrey S. Brault
Principal Investigator
Mayo Clinic
