Hip Athroplasty Using M2a MagnumNCT03409640
Metal-on-metal Hip Replacement MRI Study
An observational study of Hip Athroplasty Using M2a Magnum, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Athroplasty Using M2a Magnum
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2014to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.
Who may be able to join
- Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.
Who cannot join
- If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
- If the patient is contraindicated for any of the diagnostic tests.
- If the patient fails to consent to participating in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
About this study
Official title: The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.
- Conditions
- Hip Athroplasty Using M2a Magnum
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Scoring change in soft tissue mass size
MRI Score - monitor number and size of soft tissue lesions
Measured: 36 months after primary device implantation
Secondary outcomes (5)
Radiographic assessment
Assess acetabular cup inclincation and version
Measured: 36 months after primary device implantation
Oxford Hip Score
Oxford Hip Score, score range 0 (worst) to 48 (best)
Measured: 36 months after primary device implantation
UCLA Activity Score
UCLA activity scale, range: 1 defined as "no physical activity, dependent on others" to 10 defined as "regular participation in impact sports."
Measured: 36 months after primary device implantation
EQ-5D
EQ-5D Index score; Patient Reported Outcome
Measured: 36 months after primary device implantation
Metal Ion Levels
Chromium and Cobalt metal ion levels in blood
Measured: 36 months after primary device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start17 Jan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Athroplasty Using M2a MagnumStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409640
- Sponsor's protocol ID
- ORTHO.CR.GH34
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
- ClinicalTrials.gov ID
- NCT03409640
- Acronym / sponsor ID
- ORTHO.CR.GH34
- Conditions
- Hip Athroplasty Using M2a Magnum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Jan 2018 (actual)
- 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.
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving either the M2a Magnum or M2a 38mm Metal on Metal primary hip replacement devices from a single study centre.
Key inclusion criteria (1 listed)
- Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.
Key exclusion criteria (3 listed)
- If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
- If the patient is contraindicated for any of the diagnostic tests.
- If the patient fails to consent to participating in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MRI Scoring change in soft tissue mass size
Time frame: 36 months after primary device implantation
MRI Score - monitor number and size of soft tissue lesions
5 secondary outcomes
Radiographic assessment
Time frame: 36 months after primary device implantation
Oxford Hip Score
Time frame: 36 months after primary device implantation
UCLA Activity Score
Time frame: 36 months after primary device implantation
EQ-5D
Time frame: 36 months after primary device implantation
Metal Ion Levels
Time frame: 36 months after primary device implantation
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 24 Jan 2018.
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 Hip Athroplasty Using M2a Magnum, run by Zimmer Biomet at 1 site in United Kingdom.
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 1 inclusion and 3 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 24 Jan 2018. 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 United Kingdom. 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?
MRI Scoring change in soft tissue mass size (time frame: 36 months after primary device implantation). 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 24 Jan 2018.