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Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases

NCT02508831 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-10-05

No results posted yet for this study

Summary

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.

Conditions

  • Bilateral Amputation of Upper Limb

Interventions

PROCEDURE

Double upper limb allograft

Patients with bilateral amputation of upper limb will receive a double upper limb allograft

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-07
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02508831 on ClinicalTrials.gov