Use of FlexHD as a Post-Trapeziectomy Spacer in Patients Treated for Thumb Basal Joint Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Functionality
研究概览
简要总结
The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.
详细描述
Subjects will be followed for 12 months post basilar joint arthroplasty procedure with an interposition arthroplasty technique using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores, quality of life and trapezial space on radiographs are compared to their preoperative scores. Study visits will coincide with standard clinical course visits including: Pre-operative visits and follow-up visits at week 6, month 6, and year 1 post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 否
入选标准
- •Male or Female >18 years of age
- •Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
- •Basilar Joint Arthritis Eaton Stage III or IV
- •Be in good health other than the arthritis
- •Have realistic expectations of surgical results
- •Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
排除标准
- •Have collagen-vascular, connective tissue, or bleeding disorders
- •Be a smoker or have smoked in last 2 months
- •Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
- •Have regional sympathetic dystrophy
- •Be pregnant, lactating or expecting to be within the next 24 months
研究组 & 干预措施
Arthroplasty without HADM
Three - five (3 - 5) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the basilar joint arthroplasty procedure without using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of twenty-five (25) similar subjects who received the arthroplasty procedure with the use of the HADM spacer.
干预措施: Arthroplasty (Procedure)
Arthroplasty with HADM
Twent-five (25) subjects with Eaton stage III-IV thumb CMC osteoarthritis undergo the basilar joint arthroplasty procedure with an interposition arthroplasty technique using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores and quality of life questionnaires are compared to their preoperative scores. These subjects will be compared with a group of three - five (3 - 5) similar subjects who received the arthroplasty procedure without the use of the HADM spacer.
干预措施: Arthroplasty (Procedure)
结局指标
主要结局
Functionality
时间窗: 12 months
The objective of this study is to determine whether utilizing HADM will result in increased functionality measured by: * DASH score * Pinch and grip strength * Pain scale * Quality of life scores and * Trapezial space on radiographs at designated intervals during the post-operative period
次要结局
未报告次要终点
研究者
David Kulber, MD
Director Plastic Surgery, Center of Excellence, Cedars Sinai; Clinical Professor of Surgery, USC Keck School of Medicine
Cedars-Sinai Medical Center