search
Back to results

Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Air- Limb
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases focused on measuring Transtibial amputees due to vascular diseases.

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Transtibial amputees due to vascular diseases.

Exclusion Criteria:

  • Bilateral amputation.
  • Upper extremity can't bear weight.
  • The sound leg can't bear weight.
  • Amputee that needs Dialysis treatment.
  • Cognitive impairment.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
    The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.

    Secondary Outcome Measures

    The duration of stump healing and functional status of transtibial amputees.

    Full Information

    First Posted
    February 4, 2008
    Last Updated
    February 14, 2008
    Sponsor
    Sheba Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00616668
    Brief Title
    Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
    Official Title
    Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to check whether an early adjustment of the Air-Limb prosthesis to Transtibial amputees due to vascular diseases, will shorten the healing time of the stump and the process of rehabilitation.
    Detailed Description
    The method of immediate adjustment of a temporary Prosthesis has been developed in the past, aiming to reduce the healing time of the stump and the process of rehabilitation. According to this method, a temporary Prosthesis is being adjusted immediately after amputation, or during the first week after it. Rehabilitation starts with the patient's standing while partial weight bearing on the Prosthesis. In spite of many experiments and trials to adopt this process of rehabilitation, it is not universally adopted, because of the bad adjustment and damages to the stump caused by the Plaster of Paris. At present, with the improvement of materials and research experiments are being renewed, to check the efficiency of the process, using the Air- Limb a temporary Prosthesis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vascular Diseases
    Keywords
    Transtibial amputees due to vascular diseases.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Air- Limb
    Primary Outcome Measure Information:
    Title
    The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.
    Time Frame
    1-4 month
    Title
    The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.
    Time Frame
    2-6 month
    Secondary Outcome Measure Information:
    Title
    The duration of stump healing and functional status of transtibial amputees.
    Time Frame
    1-6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Transtibial amputees due to vascular diseases. Exclusion Criteria: Bilateral amputation. Upper extremity can't bear weight. The sound leg can't bear weight. Amputee that needs Dialysis treatment. Cognitive impairment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Itzhak Siev- Ner, MD
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

    We'll reach out to this number within 24 hrs