NCT02793726

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 11, 2023

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

May 23, 2016

Last Update Submit

May 9, 2023

Conditions

Prostheses and Implants

Keywords

Hip Prosthesis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Symptomatic

Patients with pain and or other sign of prothesis failure

Procedure: NMR

Asymptomatic

Patients with regular clinical and radiographic evolution of the implant. No pain

Procedure: NMR

Interventions

NMRPROCEDURE

NMR

AsymptomaticSymptomatic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients wearing MoM (Metal on Metal) hip prosthesis, head \>= 36 mm

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica

Bologna, 40136, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 8, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 11, 2023

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Locations

IT(1)