Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Changes in functional recovery from baseline to 5 years after the transplant of upper limbs
研究概览
简要总结
The case of patients with amputation of forearm on one side and arm on the other is particularly interesting to study because in this situation of handicap greater than a double amputation in forearm. We should bring a functional benefit to the patient with the transplant of forearm and this situation allows to have the best possible control to compare the result of the transplant of arm to that of forearm because it is realized at the same patient.
Amputation of both arms deprives patients of an elbow what establishes a major factor of limitation of autonomy and makes patients totally dependent for the realization of the essential gestures of the current life requiring the prehension (dress, dressing, food, hygiene of the elimination). The various equipments are not always adaptable and usable. Psychologically, an amputation in arm is unanimously considered as an infringement very badly accepted of the physical integrity and establishes a major handicap factor of family, professional and social exclusion.
The results of this study should allow a better appreciation of indications and modalities of care of biamputed patients with at least one lesion level above the elbow.
This clinical research will determine the potential place of a reconstructive surgery as allograft in biamputed patients on the basis of functional results and assessment of disorders of the body schema perception.
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
- •Men and women
- •Bilateral amputation of upper limb regardless of the nature of the injury (crush, tearing, cutting, infectious such as purpura fulminans...) except for tumor diseases
- •Lesion level:
- •The non-transplant patients-free immunosuppressive therapy: bilateral amputation of upper limb with at least one lesion level above the elbow. Higher amputation level is fixed to the upper 1/4 of the arm to allow for a recovery of active flexion of the elbow against gravity.
- •For organ transplant patients (other than hand or upper extremity: ex liver, kidney) and already under bi - or tri-therapy immunosuppressive : bilateral amputation of upper limb with at least one lesion level above the elbow. The top level of amputation may be above the upper 1/4 of the arm especially if body image disorders dominate the complaint of the patient.
- •Period since amputation of at least 6 months
- •Failure of all currently available (including the prosthetic) support modalities
- •Psychological maturity: absence of serious disorder of the personality or chronic disorders of mood reported by psychiatrists of the team using tests for the assessment of personality, committed and voluntary patients
- •Signature of the free and informed consent form
排除标准
- •Mono-amputee patient
- •Patients with brachial plexus lesions
- •Patients with vascular disorders likely result in thrombosis
- •Active smoking patients
- •Patients in an emergency medical situation
- •Antecedent of malignant tumor in remission for less than 5 years
- •Patients with malignant tumor
- •Patients with a American Society of Anesthesiology (ASA) score > 3
- •Patients with glomerular filtration < 60 ml/min
- •Patients with severe hypertension : Systolic Blood Pressure (SBP) > 140 mmHg and Diastolic Blood Pressure (DBP) > 90 mmHg
研究组 & 干预措施
Bilateral amputation of upper limb
Patients with bilateral amputation of upper limb will receive a double upper limb allograft
干预措施: Double upper limb allograft (Procedure)
结局指标
主要结局
Changes in functional recovery from baseline to 5 years after the transplant of upper limbs
时间窗: Before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after a double transplant of upper limbs.
Functional results assessed by a multidimensional evaluation: * A general clinical assessment * An analytical assessment: * Articular : Total Active Motion (TAM) as a percentage of Total Passive Motion (TPM) * Muscle: manual muscle strength testing and quantitative by Jamar dynamometers * A sensory and proprioceptive balance: sensitivity on mapping of WINN-PARRY, with assessment of sensitivity of protection and discriminative touch mobile and static touch, Moving Two Points Distance, Static Two Points Distance (Weber test). * A functional balance based on: DASH test, Carroll test, balance of 400 points, tests of independence and Hand Transplantation Score System (HTSS) * Impact on quality of life: measured by the Medical Outcome Study Short Form-36 (MOS SF-36)
次要结局
- Brain plasticity post-transplant(Before intervention, then 3, 6, 12, 18 and 24 months after the transplant.)
- Chronic rejection rate in post-transplant period(Throughout the five years of follow-up)
- Walking analysis in posturography(To be carried out before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant)
- Patients body image perception(To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant)
- Patients' self-esteem(To be measured before the transplant, then at 6 months, 1, 2, 3, 4 and 5 years after transplant)
- Acute rejection rate in post-transplant period(To be measured at 6 months, 1, 2, 3, 4 and 5 years after transplant)