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

Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616668
• Other study ID #: SHEBA-07-2718-AK-CTIL
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2008
• Last updated: February 14, 2008
• Start date: January 2003
• Est. completion date: December 2005

Study information

• Verified date: February 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• Air- Limb

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.		1-4 month
Primary	The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.		2-6 month	No
Secondary	The duration of stump healing and functional status of transtibial amputees.		1-6 month	No