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

Prostheses and Implants Clinical Trial

— MoM_&_3Tesla  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793726
• Other study ID #: MoM and 3 Tesla
• Status: Completed
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2016
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Prostheses and Implants

Intervention

Procedure:
• NMR
NMR

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of pseudotumor	First NMR will be offered to patients in a period comprised between 3 and 6 yrs from surgery	at first NMR, between 3 and 6 yrs from surgery