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.
|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|
- 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 ]
- The duration of stump healing and functional status of transtibial amputees. [ Time Frame: 1-6 month ] [ Designated as safety issue: No ]
|Study Start Date:||January 2003|
|Study Completion Date:||December 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616668
|Study Director:||Itzhak Siev- Ner, MD||Sheba Medical Center|