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OpenTrials
Completed

NCT Number: NCT00616668

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

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Air- Limb

Device

Primary outcomes

  1. The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.

    Time frame: 1-4 month

  2. 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 outcomes

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

    Time frame: 1-6 month

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Feb 15, 2008
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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