An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Electrical signal quality between implanted electrodes and test prosthesis
研究概览
简要总结
This early feasibility study proposes to evaluate use of the electronic-Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) device, a transhumeral implant system for direct skeletal anchorage of amputation prostheses, with a test prosthesis. The e-OPRA System is being investigated to better understand the ability to improve the functionality of the prosthesis and enhance the sense of embodiment of the prosthesis itself. This will be a 10 subject Early Feasibility Study in which the primary objective is to capture preliminary safety and effectiveness information on the implanted e-OPRA system. With the addition of electrodes to the muscle segments, this biological interface allows for both the extraction of fine motor control signals from the nerve fascicles and the generation of sensory percepts via electrical stimulation of the muscles. In addition, electrodes placed on muscles within the residuum with native vascularization and innervation also allow the extraction of critical motor control signals and the generation of sensory feedback through muscle stimulation. The electrical activity recorded from these muscle segments (called electromyography or EMG) is specific to certain movements and can be used to determine precisely how a person wants to move their arm and hand. Use of the e-OPRA device with the well-documented neuro-electronic capabilities of EMG control systems provides an alternative to traditional socket prostheses by establishing a direct, loadbearing link between the patient's skeleton and prosthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 22-65 at the time of surgery.
- •The patient must have one of the following medical conditions:
- •A condition requiring performance of a unilateral transhumeral amputation;
- •An existing transhumeral OPRA device implanted under IDE G150155;
- •An existing unilateral transhumeral amputation; or
- •An existing unilateral transhumeral amputation with previous nerve reinnervation surgery.
- •The patient must have a residual humerus of greater than or equal to 10 cm.
- •The patient must have a cortical thickness of at least 1.5 mm.
- •The patient must have at least a portion of biceps and triceps muscles present.
- •The subject must have undergone consultation with at least two upper extremity surgical specialists to ensure they have exhausted all limb salvage options prior to undergoing amputation.
- •The patient must have adequate bone stock to support the implanted device.
- •In the opinion of the Investigators, normal cognitive function and absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude patient from being a good surgical and/or study candidate.
- •Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
- •Written informed consent to participate in the study provided by the patient or legal representative.
排除标准
- •Women who are pregnant, lactating, or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
- •Arthrosis of the ipsilateral glenohumeral joint by radiographs.
- •Subjects who have not been completely abstinent from tobacco use for at least 6 weeks preoperatively.
- •Active or dormant infection.
- •Evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy, neuropathic disease, severe phantom pain, or osteoporosis, such that, in the opinion of the Investigator, the subject will not be a good study candidate.
- •History of systemically administered corticosteroids, immunosuppressive therapy, or chemotherapeutic drugs within six (6) months of implant surgery.
- •Severe medical co-morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, other indwelling electronic implants, mental incapacity, substance abuse, shortened life expectancy, and vulnerable patient population).
- •Current involvement in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
结局指标
主要结局
Change in Electrical signal quality between implanted electrodes and test prosthesis
时间窗: Baseline, 24 months
Efficacy will be evaluated by signal-to-noise ratio during maximum voluntary contraction of at least two independent myoelectric signals.
Adverse Events
时间窗: 24 Months Post-Op
Safety will be evaluated by assessing the adverse event type, incidence, timing, severity, treatment, outcome, and relationship to the device.
次要结局
- Number of Subjects with 2 or more Degrees of Freedom(Baseline, 24 months)
- Change in Pain Level as measured by LANSS surveys(Baseline, 24 months)
- Change in prosthetic functionality and performance as measured by the SHAP (Southhampton Hand Assessment Procedure)(Baseline, 24 months)
- Change in prosthetic functionality and performance as measured by the AM-ULA (Activities Measure for Upper Limb Amputees)(Baseline, 24 months)
- Change in prosthetic functionality and performance as measured by the UEFT (Upper Extremity Function Test)(Baseline, 24 months)
- Change in Pain Level as measured by SF-36(Baseline, 24 months)
- Change in Pain Level as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Questionnaire(Baseline, 24 months)
- Change in prosthetic functionality as measured by the DASH Questionnaire(Baseline, 24 months)
- Change in Pain Level as measured by DVPRS (Defense and Veterans Pain Rating Scale)(Baseline, 24 months)
- Change in Quality of Life as measured by the EQ-5D-5L Questionnaire(Baseline, 24 months)
研究者
Paul Cederna
Robert Oneal Professor of Plastic Surgery, Chief of the Section of Plastic Surgery
University of Michigan