Tissue ReactionMoM_MRINCT01750606

An MRI Investigation of Soft Tissues in Total Hip Arthroplasty

An observational study of Tissue Reaction and Elevated Blood Ion Levels, run by Zimmer Biomet at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Retrospective study to comply with FDA's post-market surveillance order. The purpose of the study is to contact patients who have received a Biomet metal-on-metal product as their primary total hip arthroplasty device. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Tissue Reaction, Elevated Blood Ion Levels
How many people: 397 participants
Where: 5 sitesUnited States
Study dates: Oct 2012to Sep 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Patients who have received the indicated implants at one of four participating centers and who meet the sampling plan requirements.

Who may be able to join

patient meets the sampling plan requirements

Who cannot join

patient is contraindicated for MRI
patient fails to consent for the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Midlands Orthopaedics
Columbia, South Carolina, 29201
Ortho Michigan
Flint, Michigan, 48507
Joint Implant Surgeons
New Albany, Ohio, 43054
Texas Center for Joint Replacement
Plano, Texas, 75093
University of Utah
Salt Lake City, Utah, 84108

Other trials in United States

About this study

Read the detailed description

This study has been designed to estimate the prevalence of soft tissue changes following primary THA surgery in patients having received one of five Biomet implant types; a MOP primary THA, an M2a 38, M2a Taper, M2a Ringloc and M2a Magnum MOM primary THA device in 308-436 total patients at four centers.

The primary objective of the study is to estimate the prevalence of soft tissue changes in unbiased MoM and MoP samples. Secondary objectives are to evaluate whether the occurrence of soft tissue changes is related to any of several potential covariates including patient and implant characteristics and time in situ.

Conditions: Tissue Reaction, Elevated Blood Ion Levels

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01750606
Study group	Role	What they receive
pre-THA		Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
Metal-on-Poly		Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
M2a Magnum hip		Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
M2a38 hip		Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
M2a Ringloc hip		Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
M2a Taperloc hip		Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.

What is being measured

The primary outcome is the main question the study is designed to answer.

Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass
Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass
Measured: Patients 1 year post-implantation up to 10 years post implantation

Secondary outcomes (1)

Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb
The outcome measure will show the number of subjects in all post-operative cohorts determined to have metal ion concentrations in whole blood and serum >7ppb in each study arm.
Measured: 1 Year through 10 Years Postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Sep 2016

First posted17 Dec 2012 (estimated)
Study startOct 2012
Primary completionJul 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tissue ReactionStudies 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: Cross-sectional
Enrolment: 397 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01750606
Sponsor's protocol ID: ORTHO.CR.GH04
Other IDs: PS110005-28
Acronym: MoM_MRI
Status last verified: Feb 2026
First submitted: 6 Nov 2012
Last updated: 20 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An MRI Investigation of Soft Tissues in Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01750606
Acronym / sponsor ID: MoM_MRI / ORTHO.CR.GH04
Conditions: Tissue Reaction, Elevated Blood Ion Levels
Study type: Observational
Recruitment status: Completed
Enrolment: 397 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jul 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Posted 20 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 6

Arm	Type	Receives
pre-THA	–	–Patients who are planned but have not yet received a total hip arthroplasty. No intervention or treatment - blood draw only to be used as a surrogate baseline for metal ion exposure.
Metal-on-Poly	–	–Patients receiving a Biomet metal on poly hip implanted between January 1, 2003 and December 31, 2006.
M2a Magnum hip	–	–Patients receiving a Biomet M2a Magnum hip implanted between January 1, 2006 and January 1, 2011.
M2a38 hip	–	–Patients receiving a Biomet metal on metal M2a38 hip implanted between January 1, 2004 and December 31, 2006.
M2a Ringloc hip	–	–Patients receiving a Biomet M2a Ringloc metal on metal hip implanted between January 1, 2002 and December 31, 2004.
M2a Taperloc hip	–	–Patients receiving a Biomet M2a Taperloc metal on metal hip implanted between January 1, 2002 and December 31, 2003.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Patients who have received the indicated implants at one of four participating centers and who meet the sampling plan requirements.

Key inclusion criteria (1 listed)

patient meets the sampling plan requirements

Key exclusion criteria (2 listed)

patient is contraindicated for MRI
patient fails to consent for 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

Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass
Time frame: Patients 1 year post-implantation up to 10 years post implantation
Determine the percentage of asymptomatic vs symptomatic Metal-on-Metal and Metal-on-Poly patients with a soft tissue mass

1 secondary outcome

Number of Participants With Metal Ion Concentrations in Whole Blood and Serum > 7ppb
Time frame: 1 Year through 10 Years Postop

Results and safety

Results posted to the registry on 20 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metal-on-Poly	79	78
M2a Magnum Hip	140	137
M2a38 Hip	60	56
M2a Ringloc Hip	9	9
M2a Taperloc Hip	14	13
Pre-THA	104	104

Primary outcome: Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass

Time frame: Patients 1 year post-implantation up to 10 years post implantation. Count of participants. Unit: Participants

Measure	M2a 38mm Hip- 1 Year Cohort n = 1	M2a 38mm Hip- 6 Year Cohort n = 5	M2a 38mm Hip- 7 Year Cohort n = 26	M2a 38mm Hip- 8 Year Cohort n = 27	M2a 38mm Hip- 10 Year Cohort n = 1	M2a Magnum Hip- 1 Year Cohort n = 12	M2a Magnum Hip- 2 Year Cohort n = 20	M2a Magnum Hip- 3 Year Cohort n = 27	M2a Magnum Hip- 4 Year Cohort n = 25	M2a Magnum Hip- 5 Year Cohort n = 27	M2a Magnum Hip- 6 Year Cohort n = 28	M2a Magnum Hip- 8 Year Cohort n = 1	M2a Ringloc Hip- 8 Year Cohort n = 1	M2a Ringloc Hip- 9 Year Cohort n = 3	M2a Ringloc Hip- 10 Year Cohort n = 5	M2a Taper Hip- 9 Year Cohort n = 3	M2a Taper Hip- 10 Year Cohort n = 11	Metal on Poly Hip- 6 Year Cohort n = 25	Metal on Poly Hip- 7 Year Cohort n = 20	Metal on Poly Hip- 8 Year Cohort n = 12	Metal on Poly Hip- 9 Year Cohort n = 22
Asymptomatic	1	5	22	23	1	8	18	26	23	25	26	1	0	3	5	3	8	25	20	10	16
Symptomatic	0	0	4	4	0	4	2	1	2	2	2	0	1	0	0	0	3	0	0	2	6

Population analysed: Patients in each symptomatic group evaluated with an adverse local tissue reaction (ALTR), which is determined based on the presence of an age-related macular degeneration (ARMD) of any level of severity, detected on the MRI. Patients in each asymptomatic group evaluated without an ALTP detected on the MRI.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Surgery to 10 years post operative. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metal-on-Poly	78 of 78 (100%)	0 of 0	0 of 78
M2a Magnum Hip (1-3 Years)	58 of 58 (100%)	0 of 0	0 of 58
M2a Magnum Hip (4-8 Years)	79 of 79 (100%)	0 of 0	0 of 79
M2a38 Hip	56 of 56 (100%)	0 of 0	0 of 56
M2a Ringloc Hip	9 of 9 (100%)	0 of 0	0 of 9
M2a Taperloc Hip	13 of 13 (100%)	0 of 0	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Russell Schenck, Ph.D. study director

Zimmer Biomet

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Tissue Reaction and Elevated Blood Ion Levels, run by Zimmer Biomet at 5 sites in United States.

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 2 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

Yes. Results are posted in the registry (first posted 20 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Asymptomatic vs Symptomatic Metal-on-Metal and Metal-on-Poly Patients (Via a Proportion) With a Soft Tissue Mass (time frame: Patients 1 year post-implantation up to 10 years post implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01750606.

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 20 Feb 2026.