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CompletedNCT00616668Updated Feb 15, 2008

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

A Phase 2 interventional study of Air- Limb in Vascular Diseases, sponsored by Sheba Medical Center. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-02-15.

Sponsored by Sheba Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vascular Diseases

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Keywords

  • Transtibial amputees due to vascular diseases.
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 20 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Transtibial amputees due to vascular diseases.

Exclusion criteria

Exclusion Criteria:

  • Bilateral amputation.
  • Upper extremity can't bear weight.
  • The sound leg can't bear weight.
  • Amputee that needs Dialysis treatment.
  • Cognitive impairment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
20 participants (actual)

Interventions

  • DeviceAir- Limb
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00616668
Lead sponsor
Sheba Medical Center
First posted
Feb 15, 2008
Start date
Jan 2003
Completion
Dec 2005
Last update
Feb 15, 2008

Study contacts

Itzhak Siev- Ner, MD
study director · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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