Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Range of Motion
研究概览
简要总结
The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer.
As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure.
The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.
详细描述
The investigators central hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options. The overall aim of the project is to validate the clinical use of AAM for the treatment of early-stage osteoarthritis of the hand in adult patients (>18 years of age). The specific aims for this project are:
- To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand
a. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points 2. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength
a. To determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with DASH scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points 3. To determine patient satisfaction with the procedure a. To determine patient satisfaction, the investigators will administer a survey at each of the follow up time points
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints).
- •Radiographic evidence of osteoarthritis.
排除标准
- •Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).
- •Rheumatoid or other inflammatory arthritis condition
- •Collagen vascular disease
- •Pregnancy or breast-feeding
- •Congestive heart failure
- •Chronic obstructive pulmonary disease
- •Chronic renal failure
- •Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).
研究组 & 干预措施
Adipose Allograft Matrix (AAM)
Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.
干预措施: local anaesthetic injection (Drug)
Adipose Allograft Matrix (AAM)
Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.
干预措施: Human Adipose Allograft (Procedure)
结局指标
主要结局
Range of Motion
时间窗: 12 months
Measured with a standardized goniometer
Strength Measures
时间窗: 12 months
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Pain scale scores
时间窗: 12 months
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Disability Measurement
时间窗: 12 months
DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Patient satisfaction
时间窗: 12 months
Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.
次要结局
- Incidence of Adverse Events(0-12 months)
研究者
Meghan McCullough, MD
Principal Investigator
Cedars-Sinai Medical Center