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

Completed

• Conditions: Prostheses and Implants
• Interventions: Procedure: NMR

• Registration Number: NCT02793726
• Lead Sponsor: Istituto Ortopedico Rizzoli

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-23
• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-03
• Study First Posted: 2016-06-08
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asymptomatic	NMR	Patients with regular clinical and radiographic evolution of the implant. No pain
Symptomatic	NMR	Patients with pain and or other sign of prothesis failure

Primary Outcome Measures

Name	Time	Method
Presence of pseudotumor	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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica; 🇮🇹 Bologna, Italy