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

This study has been completed.
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: February 2008
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The duration of stump healing and functional status of transtibial amputees. [ Time Frame: 1-6 month ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00616668

Sponsors and Collaborators
Sheba Medical Center
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 
Study First Received: February 4, 2008
Last Updated: February 14, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 26, 2016