ClinicalTrials.gg
CompletedNCT03450733Updated Oct 13, 2022

Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study

An observational study in Osteoarthritis, Hip, Hip Disease and Hip Osteoarthritis, sponsored by MicroPort Orthopedics Inc.. Completed at 4 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.

Sponsored by MicroPort Orthopedics Inc. (part of MicroPort Scientific Corporation) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
173
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 155 studies in Osteoarthritis, Hip with a site in United States — 21 open to participants now, 32 under way, 1 of them phase 3. Osteoarthritis, Hip · United States.

Enrollment
15th of 34
173 · median 120
Started
2018
with 13 others
Observational
35 of 155
5 open now
Registered
74th of 155
by date

Among the 155 studies in Osteoarthritis, Hip with a site in United States, this one is the 15th largest by enrollment of the 34 observational ones that give a count, is one of 14 that started in 2018, is one of 35 observational ones, and was the 74th registered.

Osteoarthritis, Hip

641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.

Browse Osteoarthritis, Hip studies →

Open to participants now

21 of the 155 studies in Osteoarthritis, Hip with a site in United States are open now. Recruiting first, the newest first:

16 more — sign in →

All 21 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 87 Osteoarthritis, Hip studies recruiting now, 54 (62%) set no upper age limit and 7 (8%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and > 8 years, since implantation.

03

Conditions studied

  • Osteoarthritis, Hip
  • Hip Disease
  • Hip Osteoarthritis
  • Joint Pain

Keywords

  • Metal-on-Metal
  • MOM
  • Total Hip Arthroplasty
  • THA
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Group 1: Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System

Group 2: Control, non-implanted subjects

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

To be included in Group 1, subjects must meet all of the following criteria:

  1. Has been implanted with appropriate components of the WMT MOM THA System
  2. Has previously undergone primary THA for any of the following:

    1. non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
    2. inflammatory degenerative joint disease including rheumatoid arthritis;
    3. correction of functional deformity.
  3. Is willing and able to complete required study visit(s) and assessments
  4. Plans to be available for the required study visit
  5. Is capable of providing sufficient blood for sampling according to blood draw procedures
  6. Is willing to sign the approved document

Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement and protocol enrollment strategy, and 4) the subject agrees to a second Informed Consent document and data collection specific to the second THA. Enrollment and treatment of a previously unimplanted hip is not permitted in this study.

To be included in Group 2, subjects must meet all of the following criteria:

  1. Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
  2. Is not an employee of the Investigator
  3. Is willing and able to provide Informed Consent document
  4. Is willing and able to attend the requested study visit(s) and assessments
  5. Is capable of providing sufficient blood for sampling according to blood draw procedures

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from either study group if they meet any of the following criteria:

  1. Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
  2. Subject is unwilling or unable to sign the document
  3. Subject has documented substance abuse issues
  4. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  5. Subject is currently incarcerated or has impending incarceration
  6. Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
  7. Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
173 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Previously Implanted (Group 1)

    Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System

    Device: Wright Medical Technology Metal-on-Metal Total Hip System

  • Control (Group 2)

    Control, non-implanted subjects

Interventions

  • DeviceWright Medical Technology Metal-on-Metal Total Hip System

    Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records. Collected data will be evaluated in aggregate and cross-sectioned by year of implantation. Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months). Subject data will be grouped in order to create cross-sectional epochs of ≤ 8 years and \> 8 years.

06

What researchers measure

Primary outcomes

  1. Rate of Adverse Local Tissue Reactions (ALTR)

    To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)

    Time frame: ≤ 8 years and > 8 years, since implantation

Secondary outcomes

  1. Determine chromium and cobalt whole blood and serum ion levels across time intervals

    Cobalt and chromium metal ion levels will be measured in whole blood and serum from subjects implanted with the WMT MoM THA System (Group 1) at each defined cross-section interval.

    Time frame: ≤ 8 years and > 8 years, since implantation

  2. Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals

    Analyze difference in chromium and cobalt whole blood and serum ion levels in subjects implanted with the WMT MoM THA System (Group 1) versus control subjects (Group 2) cross-sectionally.

    Time frame: ≤ 8 years and > 8 years, since implantation

  3. Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).

    Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR

    Time frame: ≤ 8 years and > 8 years, since implantation

  4. Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).

    Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR

    Time frame: ≤ 8 years and > 8 years, since implantation

07

Study locations

4 sites
  • TriWest Research Associates
    El Cajon, California 92020, United States
  • BioSolutions Research Center
    La Mesa, California 91942, United States
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • Spokane Joint Replacement Center, Inc.
    Spokane, Washington 99208, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Nov 2021, 43 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2018
First posted
Mar 1, 2018
StartActual
Apr 11, 2018
Primary completionActual
Nov 24, 2021
CompletionActual
Jun 18, 2022
Last update
Oct 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03450733
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Apr 11, 2018
Primary completion
Nov 24, 2021
Completion
Jun 18, 2022
Last update
Oct 13, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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