A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- The study primary endpoint is a composite endpoint to determine the proportion of participants who are successful on the primary effectiveness and safety endpoints (overall success) at 2 years
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
详细描述
This study is a prospective, multicenter, single-arm, open-label study in skeletally mature participants with transfemoral limb loss (unilateral or bilateral), without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis.
Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1.
Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol.
Events of special interest include superficial and deep infections at the implant site, failures, and secondary surgical interventions; participants will be followed for all soft tissue interface issues.
Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6, 12, 18, and 24 and annually through 5 years post-implantation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures.
- •Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Participants < 22 years of age require radiographic confirmation of skeletal maturity and must have failed the use of conventional prosthesis.
- •Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
- •Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
- •Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a socket prosthesis in the investigator's judgment.
- •Participant has adequate bone stock to support the implanted device
- •Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
- •Participant has the willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
排除标准
- •Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
- •Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
- •Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day
- •Participant has any distant foci of infections.
- •Participant has a history of sepsis within 6 months prior to Study Day
- •Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
- •Participant has a femoral deformity that in the opinion of the treating surgeon results in an inability to properly insert the Transdermal Compress implant system, and/or results in alignment that is biomechanically unsound.
- •Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
- •Participant has evidence of or history of severe peripheral vascular disease or insufficiency, muscular atrophy, neuromuscular disease, or diabetes mellitus (Type I or Type II).
- •Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
- •Participants with identified risk factors for osteoporosis must have a reported T-score > -2.5 within 6 months prior to Study Day
- •Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
- •Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
- •Participant has known drug or alcohol dependence currently or within the last year.
- •Participant is a smoker, nicotine, or tobacco user in any form or who has used nicotine or tobacco-containing products within the past 6 months prior to Study Day
- •Participant has any other condition, which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined
研究组 & 干预措施
Transdermal Compress Device
The Transdermal Compress device is a bone-anchored transdermal implant that addresses the shortcomings of a socket prosthesis and provides options to amputees who are not able to utilize a conventional socket prosthesis.
干预措施: Transdermal Compress Device (Device)
结局指标
主要结局
The study primary endpoint is a composite endpoint to determine the proportion of participants who are successful on the primary effectiveness and safety endpoints (overall success) at 2 years
时间窗: Two (2) years post-implantation
The following endpoint components will be used to assess effectiveness in the composite endpoint: Prosthetic Wear Time PROMIS Physical Function OPUS Satisfaction with Devices and Services The following will be used to assess safety in the composite endpoint: Lack of secondary surgical intervention. No more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation. Radiographic success.
次要结局
- Orthotics and Prosthetics Users Survey: Satisfaction with Devices(Two and Five (2-5) years post-implantation)
- A composite endpoint will be evaluated to determine the proportion of participants who are successes on both the primary effectiveness and safety endpoints at 2 years and 5 years.(Two (2) and Five (5) years post-implantation)
- Type and frequency of mechanical complications over time.(Two (2) and Five (5) years post-implantation)
- Patient Reported Outcome Measurement Information System: Pain Behavior(Two (2) and Five (5) years post-implantation)
- Lack of secondary surgical intervention(Two (2) and Five (5) years post-implantation)
- Prosthetic Wear Time(Two (2) and Five (5) years post-implantation)
- Patient Reported Outcome Measurement Information System: Physical Function(Two (2) and Five (5) years post-implantation)
- Overall infection rate(Two (2) and Five (5) years post-implantation)
- Patient Reported Outcome Measurement Information System: Pain Intensity(Two (2) and Five (5) years post-implantation)
- Patient Reported Outcome Measurement Information System: Pain Interference(Two (2) and Five (5) years post-implantation)
- The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.(Two (2) years post-implantation)
- The proportion of participants who have had serious device-related adverse events.(Two (2) and Five (5) years post-implantation)