AMI Construction in Lower Extremity Residual Limbs
キーワード
概要
説明
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
日付
| 最終確認済み: | 03/31/2020 |
| 最初に提出された: | 06/14/2019 |
| 提出された推定登録数: | 08/15/2019 |
| 最初の投稿: | 08/20/2019 |
| 最終更新が送信されました: | 04/07/2020 |
| 最終更新日: | 04/08/2020 |
| 実際の研究開始日: | 03/31/2020 |
| 一次完了予定日: | 08/31/2022 |
| 研究完了予定日: | 08/31/2022 |
状態または病気
介入/治療
Procedure: Intervention
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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) |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
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]
