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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616668

Enrollment

Registered

2008-02-15

Start date

2003-01-31

Completion date

2005-12-31

Last updated

2008-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Diseases

Keywords

Transtibial amputees due to vascular diseases.

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.

Interventions

DEVICEAir- Limb

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
The duration of rehabilitation of transtibial amputees, from amputation until the fitting of the permanent prosthesis.	1-4 month
The total duration of the rehabilitation process,from amputation until the end of the hospitalization, with the permanent prosthesis.	2-6 month

Secondary

Measure	Time frame
The duration of stump healing and functional status of transtibial amputees.	1-6 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026