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

Sheba Medical Center

Status and phase: Completed; Phase 2

Conditions: Vascular Diseases

Treatments: Device: Air- Limb

Study type: Interventional

Funder types: Other

Identifiers

NCT00616668

SHEBA-07-2718-AK-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind