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Clinical Trials/NCT02793726
NCT02793726
Completed
Not Applicable

The Effects of Large Head Metal on Metal (MOM) Hip Prosthesis on Soft Tissue: Study With 3 Tesla Nuclear Magnetic Resonance (NMR)

Istituto Ortopedico Rizzoli1 site in 1 country30 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostheses and Implants
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
30
Locations
1
Primary Endpoint
Presence of pseudotumor
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic Resonance).

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 2017
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients wearing MoM hip prosthesis
  • Head \>= 36 mm

Exclusion Criteria

  • Presence of ferromagnetic implants and/or presence of clinical situations that are not compatible with NMR

Outcomes

Primary Outcomes

Presence of pseudotumor

Time Frame: at first NMR, between 3 and 6 yrs from surgery

First NMR will be offered to patients in a period comprised between 3 and 6 yrs from surgery

Study Sites (1)

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