Osteoarthritis, HipNCT03450733
Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study
An observational study of Osteoarthritis, Hip and Hip Disease, run by MicroPort Orthopedics Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Hip Disease, Hip Osteoarthritis
- What is being tested?
- Wright Medical Technology Metal-on-Metal Total Hip System
- Type of treatment
- Medical device
- How many people
- 173 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Apr 2018to 18 Jun 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- To be included in Group 1, subjects must meet all of the following criteria:
- Has been implanted with appropriate components of the WMT MOM THA System
- Has previously undergone primary THA for any of the following:
- non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity.
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- Is willing and able to complete required study visit(s) and assessments
- Plans to be available for the required study visit
- Is capable of providing sufficient blood for sampling according to blood draw procedures
- Is willing to sign the approved Informed Consent 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:
- Does not have a metal implant (total hip, total knee, spinal, etc.) with the exception of dental implants
- Is not an employee of the Investigator
- Is willing and able to provide Informed Consent document
- Is willing and able to attend the requested study visit(s) and assessments
- Is capable of providing sufficient blood for sampling according to blood draw procedures
Who cannot join
- Subjects will be excluded from either study group if they meet any of the following criteria:
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Subject is currently incarcerated or has impending incarceration
- Group 1 only: Subject has a condition or previously implanted medical device that contraindicates MRI (e.g. pacemaker, implantable defibrillator)
- Group 1 only: Subject was skeletally immature (less than 21 years of age) at time of implantation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
TriWest Research Associates
El Cajon, California, 92020
University of Iowa
Iowa City, Iowa, 52242
BioSolutions Research Center
La Mesa, California, 91942
Spokane Joint Replacement Center, Inc.
Spokane, Washington, 99208
About this study
Official title: Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)
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.
- Conditions
- Osteoarthritis, Hip, Hip Disease, Hip Osteoarthritis, Joint Pain
- Being tested
- Wright Medical Technology Metal-on-Metal Total Hip System
- Keywords
- Metal-on-Metal, MOM, Total Hip Arthroplasty, THA
- Medical subject headings
- Osteoarthritis, Hip, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wright Medical Technology Metal-on-Metal Total Hip SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Previously Implanted (Group 1) | Subjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System Receives: Device: Wright Medical Technology Metal-on-Metal Total Hip System | |
| Control (Group 2) | Control, non-implanted subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse Local Tissue Reactions (ALTR)
To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
Measured: ≤ 8 years and > 8 years, since implantation
Secondary outcomes (4)
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.
Measured: ≤ 8 years and > 8 years, since implantation
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.
Measured: ≤ 8 years and > 8 years, since implantation
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
Measured: ≤ 8 years and > 8 years, since implantation
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
Measured: ≤ 8 years and > 8 years, since implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start11 Apr 2018
- Primary completion24 Nov 2021
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by MicroPort Orthopedics Inc.The 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
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450733
- Sponsor's protocol ID
- 11LJH001
- Status last verified
- Oct 2022
- First submitted
- 23 Feb 2018
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)
- ClinicalTrials.gov ID
- NCT03450733
- Acronym / sponsor ID
- 11LJH001
- Conditions
- Osteoarthritis, Hip, Hip Disease, Hip Osteoarthritis, Joint Pain
- Keywords
- Metal-on-Metal, MOM, Total Hip Arthroplasty, THA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 1 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously Implanted (Group 1) | – | Device: Wright Medical Technology Metal-on-Metal Total Hip SystemSubjects previously implanted with components of the Wright Medical Technology (WMT) Metal-on-Metal (MoM) Total Hip Arthroplasty (THA) System |
| Control (Group 2) | – | –Control, non-implanted subjects |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- Has been implanted with appropriate components of the WMT MOM THA System
- Has previously undergone primary THA for any of the following:
- Is willing and able to complete required study visit(s) and assessments
- Plans to be available for the required study visit
- Is capable of providing sufficient blood for sampling according to blood draw procedures
Key exclusion criteria (8 listed)
- Subjects will be excluded from either study group if they meet any of the following criteria:
- Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subject is unwilling or unable to sign the Informed Consent document
- Subject has documented substance abuse issues
- Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wright Medical Technology Metal-on-Metal Total Hip SystemSubjects 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. | Device | Previously Implanted (Group 1) |
Primary outcome
Rate of Adverse Local Tissue Reactions (ALTR)
Time frame: ≤ 8 years and > 8 years, since implantation
To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)
4 secondary outcomes
Determine chromium and cobalt whole blood and serum ion levels across time intervals
Time frame: ≤ 8 years and > 8 years, since implantation
Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals
Time frame: ≤ 8 years and > 8 years, since implantation
Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Time frame: ≤ 8 years and > 8 years, since implantation
Compare cobalt and chromium metal ion levels in subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects).
Time frame: ≤ 8 years and > 8 years, since 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 13 Oct 2022.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Hip Disease, run by MicroPort Orthopedics Inc. at 4 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 17 inclusion and 8 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Rate of Adverse Local Tissue Reactions (ALTR) (time frame: ≤ 8 years and > 8 years, since 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 13 Oct 2022.