Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem

December 22, 2021 updated by: MicroPort Orthopedics Inc.
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads.

Description

Inclusion Criteria:

  1. Has previously undergone or currently has been determined to undergo a primary THA with the study component MPO PROFEMUR® Preserve Classic Stem combined with any type of polyethylene or ceramic acetabular shells, acetabular liners and femoral heads.

  2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:

    • non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
    • inflammatory degenerative joint disease such as rheumatoid arthritis;
    • correction of functional deformity
  3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
  4. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.

Exclusion Criteria:

  1. Skeletally immature (less than 21 years of age) at time of implantation
  2. Has or had an overt infection at the time of implantation
  3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
  4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
  5. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
  6. Has or had neuropathic joints
  7. Has or had hepatitis or HIV infection
  8. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
  9. Has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
  10. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
  11. Has or had documented substance abuse issues
  12. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
  13. Currently incarcerated or has impending incarceration
  14. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Component Survivorship
Time Frame: 10 years post-operative
To estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem at 1, 3, 5, 7, 10 years.
10 years post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HOOS Functional Scores
Time Frame: 10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores as assessed by the Hip Disability and Osteoarthritis Outcome Score (HOOS), which ranges from 0 to 100 with a score of 0 indicating worst hip symptoms and 100 indicating no hip symptoms.
10 years post-operative
EQ-5D-5L Functional Scores
Time Frame: 10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores as assessed by EQ-5D-5L. This functional score data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 5 levels: no problems, slight problem, moderate problem, severe problem, inability to perform the activity. With no problems being the best outcome and inability to perform the activity being worst outcome.
10 years post-operative
Subject Satisfaction as assessed by Forgotten Joint Score
Time Frame: 10 years post-operative
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS). The study will be reporting forgotten joint score measures for the assessment of joint-specific patient reported outcomes. The questions focus on the patients' awareness of the implanted joint in everyday life or any unintended perception of a joint.
10 years post-operative
Subject Satisfaction as assessed by Satisfaction Survey
Time Frame: 10 years post-operative
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey, consisting of questions asked about how satisfied the patient is with the new implant.
10 years post-operative
Radiolucencies
Time Frame: 10 years post-operative
To assess the presence of radiolucencies surrounding implanted components
10 years post-operative
To assess subject safety
Time Frame: 10 years post-operative
To assess safety of the PROFEMUR® Preserve Classic Femoral Stem through device-related adverse event findings and/or adverse device effects during follow-up visits.
10 years post-operative
To assess device tolerability within subject
Time Frame: 10 years post-operative
To assess tolerability of the PROFEMUR® Preserve Classic Femoral Stem through device-related adverse event findings and/or adverse device effects during follow-up visits.
10 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort Orthopedics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2033

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19H001C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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