Prostheses and ImplantsMoM_&_3TeslaNCT02793726
The Effects of Large Head MoM Hip Prosthesis on Soft Tissue: Study With 3 Tesla NMR
An observational study of Prostheses and Implants, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostheses and Implants
- What is being tested?
- NMR
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients wearing MoM (Metal on Metal) hip prosthesis, head >= 36 mm
Who may be able to join
- Patients wearing MoM hip prosthesis
- Head >= 36 mm
Who cannot join
- Presence of ferromagnetic implants and/or presence of clinical situations that are not compatible with NMR
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica
Bologna, 40136
About this study
Official title: The Effects of Large Head Metal on Metal (MOM) Hip Prosthesis on Soft Tissue: Study With 3 Tesla Nuclear Magnetic Resonance (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).
- Conditions
- Prostheses and Implants
- Being tested
- NMR
- Keywords
- Hip Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMRProcedure or surgery
NMR
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | Patients with pain and or other sign of prothesis failure Receives: Procedure: NMR | |
| Asymptomatic | Patients with regular clinical and radiographic evolution of the implant. No pain Receives: Procedure: NMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pseudotumor
First NMR will be offered to patients in a period comprised between 3 and 6 yrs from surgery
Measured: at first NMR, between 3 and 6 yrs from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostheses and ImplantsStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793726
- Sponsor's protocol ID
- MoM and 3 Tesla
- Acronym
- MoM_&_3Tesla
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Large Head Metal on Metal (MOM) Hip Prosthesis on Soft Tissue: Study With 3 Tesla Nuclear Magnetic Resonance (NMR)
- ClinicalTrials.gov ID
- NCT02793726
- Acronym / sponsor ID
- MoM_&_3Tesla / MoM and 3 Tesla
- Conditions
- Prostheses and Implants
- Keywords
- Hip Prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | Procedure: NMRPatients with pain and or other sign of prothesis failure |
| Asymptomatic | – | Procedure: NMRPatients with regular clinical and radiographic evolution of the implant. No pain |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients wearing MoM (Metal on Metal) hip prosthesis, head >= 36 mm
Key inclusion criteria (2 listed)
- Patients wearing MoM hip prosthesis
- Head >= 36 mm
Key exclusion criteria (1 listed)
- Presence of ferromagnetic implants and/or presence of clinical situations that are not compatible with NMR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMRNMR | Procedure or surgery | Asymptomatic, Symptomatic |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostheses and Implants, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pseudotumor (time frame: at first NMR, between 3 and 6 yrs from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.