Status:

COMPLETED

Evaluation of the Stability of Osseointegrated Implant in Amputees

Lead Sponsor:

Istituto Ortopedico Rizzoli

Collaborating Sponsors:

University of Bologna

Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

Conditions:

Prosthesis Migration

Amputation

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implan...

Eligibility Criteria

Inclusion

  • BMI\<35 kg/m2
  • Problem in using socket

Exclusion

  • Diabetes;
  • Peripheral vascular diseases;
  • Psychiatric problems;
  • Pregnancy;
  • Rheumatoid arthritis;
  • Neurovascular diseases;
  • Neurological deficits;
  • Amputation of the contralateral limb;
  • Infections in progress;
  • Immunosuppression;

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 8 2024

Estimated Enrollment :

4 Patients enrolled

Trial Details

Trial ID

NCT03836755

Start Date

January 1 2019

End Date

May 8 2024

Last Update

May 24 2024

Active Locations (1)

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Istituto Ortopedico Rizzoli

Bologna, Italy, 40136