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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616668
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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.

Condition Intervention Phase
Vascular Diseases Device: Air- Limb Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Early Postoperative Fitting of the Air- Limb Prosthesis for Transtibial Amputees

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis. [ Time Frame: 1-4 month ]
  • 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 Measures:
  • The duration of stump healing and functional status of transtibial amputees. [ Time Frame: 1-6 month ]

Enrollment: 20
Study Start Date: January 2003
Study Completion Date: December 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616668


Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Itzhak Siev- Ner, MD Sheba Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00616668     History of Changes
Other Study ID Numbers: SHEBA-07-2718-AK-CTIL
First Submitted: February 4, 2008
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Sheba Medical Center:
Transtibial amputees due to vascular diseases.

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases