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

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ClinicalTrials.gov Identifier: NCT03450733
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.

Brief 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 for each yearly cross-section from 4-year to 8-year post implant.

Condition or disease Intervention/treatment
Osteoarthritis, Hip Hip Disease Hip Osteoarthritis Joint Pain Device: Wright Medical Technology Metal-on-Metal Total Hip System

Study Type : Observational
Estimated Enrollment : 255 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Post-Market Surveillance of the Wright Medical Technology Metal-on-Metal Total Hip System (FDA 522 Order)
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Subjects in Group 1 previously implanted between 4 and 8 years 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. 4 years, 5 years) using contiguous visit windows (number of years + 6 months). There will be 15 THAs collected for the Year 4 intervals and 35 THAs collected for the remaining intervals.

Control (Group 2)
Control, non-implanted subjects



Primary Outcome Measures :
  1. Rate of Adverse Local Tissue Reactions (ALTR) [ Time Frame: from 4-year to 8-year post implant ]
    To determine the incidence rate of ALTR in subjects implanted with WMT MoM THA System (Group 1)


Secondary Outcome Measures :
  1. Determine chromium and cobalt whole blood and serum ion levels across time intervals [ Time Frame: from 4-year to 8-year post implant ]
    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.

  2. Establish baseline for chromium and cobalt whole blood and serum ion levels across time intervals [ Time Frame: from 4-year to 8-year post implant ]
    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.

  3. Compare functional outcomes of subjects implanted with the WMT MoM THA System with and without ALTR (Group-1 subjects). [ Time Frame: from 4-year to 8-year post implant ]
    Calculate and compare composite hip outcomes scores, via the validated HOOS scores, in Group 1 subjects with ALTR versus Group 1 subjects without ALTR

  4. 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: from 4-year to 8-year post implant ]
    Analyze difference in cobalt and chromium metal ion levels from Group 1 subjects with ALTR versus Group 1 subjects without ALTR


Biospecimen Retention:   Samples With DNA
Whole blood and serum samples will be retained


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Criteria

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 for at least four years +/- six months (i.e., 3.5 years since implantation), but not longer than eight years and six months (i.e., 8.5 years since implantation)
  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 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:

  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:

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 Informed Consent 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450733


Locations
United States, California
TriWest Research Associates
El Cajon, California, United States, 92020
Biosolutions Clinical Research Center
La Mesa, California, United States, 91942
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Washington
Spokane Joint Replacement Center, Inc.
Spokane, Washington, United States, 99208
Sponsors and Collaborators
MicroPort Orthopedics Inc.

Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT03450733     History of Changes
Other Study ID Numbers: 11LJH001
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by MicroPort Orthopedics Inc.:
Metal-on-Metal
MOM
Total Hip Arthroplasty
THA

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthralgia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms