AMI Construction in Lower Extremity Residual Limbs
关键词
抽象
描述
The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows:
1. To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities
2. To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass
3. To determine the reinnervation time course and longevity of these biological constructs
4. To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA
5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 06/14/2019 |
| 提交的预估入学人数: | 08/15/2019 |
| 首次发布: | 08/20/2019 |
| 上次提交的更新: | 04/07/2020 |
| 最近更新发布: | 04/08/2020 |
| 实际学习开始日期: | 03/31/2020 |
| 预计主要完成日期: | 08/31/2022 |
| 预计完成日期: | 08/31/2022 |
状况或疾病
干预/治疗
Procedure: Intervention
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Intervention Subjects undergoing the proposed operative intervention. Intervention patients will serve as their own control for all outcome measures | Procedure: Intervention Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Between the ages of 18-65 - Has already undergone a standard AKA or BKA procedure - Suffers from symptoms such as: - Intractable pain - Deterioration of skin on or around stump - Suffering from other sources of discomfort arising from stump - Intact inherent wound healing - Adequate communication skills - High motivation Exclusion Criteria: - Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary) - Individuals with impaired wound healing - Individuals suffering from extensive peripheral neuropathies - Active smokers - Individuals with a history of poor compliance - Women who are pregnant or plan to become pregnant before surgical intervention |
结果
主要结果指标
1. Limb Morphology and Changes in Muscle Volume [Years 1-3]
2. Degree of Motor Activation of AMI Muscles and Volitional Control of Phantom Limb [Years 1-3]
3. Evidence of Proprioception [Years 1-3]
4. Evidence of Sensory Perception [Years 1-3]
5. General Health [Years 1-3]
6. Complications [Years 1-3]
