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OpenTrials
Completed

NCT Number: NCT02793726

The Effects of Large Head MoM Hip Prosthesis on Soft Tissue: Study With 3 Tesla NMR

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).

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Key information

Conditions

Prostheses and Implants

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NMR

Procedure

NMR

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: MoM_&_3Tesla

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 8, 2016
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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