Joint DiseasesNCT04615039
Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Diseases
- What is being tested?
- PROFEMUR® Preserve Classic Femoral Stem
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Dec 2033
- 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: 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.
Who may be able to join
- 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.
- 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
- Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
- Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.
Who cannot join
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- 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
- Has or had neuropathic joints
Show all 14Show fewer
- Has or had hepatitis or HIV infection
- Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- Has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Has or had documented substance abuse issues
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Currently incarcerated or has impending incarceration
- 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
About this study
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.
- Conditions
- Joint Diseases
- Being tested
- PROFEMUR® Preserve Classic Femoral Stem
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFEMUR® Preserve Classic Femoral StemDevice
Single study group of subjects, 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Component Survivorship
To estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem at 1, 3, 5, 7, 10 years.
Measured: 10 years post-operative
Secondary outcomes (7)
HOOS Functional Scores
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.
Measured: 10 years post-operative
EQ-5D-5L Functional Scores
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.
Measured: 10 years post-operative
Subject Satisfaction as assessed by Forgotten Joint Score
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.
Measured: 10 years post-operative
Subject Satisfaction as assessed by Satisfaction Survey
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.
Measured: 10 years post-operative
Radiolucencies
To assess the presence of radiolucencies surrounding implanted components
Measured: 10 years post-operative
To assess subject safety
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.
Measured: 10 years post-operative
To assess device tolerability within subject
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.
Measured: 10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study startDec 2021 (estimated)
- Primary completionDec 2033 (estimated)
- Study completionDec 2033 (estimated)
Why it stopped: Site selection process has been revisited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies 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
- Other
- Enrolment
- 0 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
- NCT04615039
- Sponsor's protocol ID
- 19H001C
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2020
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
- ClinicalTrials.gov ID
- NCT04615039
- Acronym / sponsor ID
- 19H001C
- Conditions
- Joint Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Site selection process has been revisited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2033 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 4 Nov 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- Has previously undergone or currently has been determined to undergo a primary THA for any of the following:
- Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
- Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.
Key exclusion criteria (14 listed)
- Skeletally immature (less than 21 years of age) at time of implantation
- Has or had an overt infection at the time of implantation
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- 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
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 |
|---|---|---|
| PROFEMUR® Preserve Classic Femoral StemSingle study group of subjects, 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. | Device | – |
Primary outcome
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.
7 secondary outcomes
HOOS Functional Scores
Time frame: 10 years post-operative
EQ-5D-5L Functional Scores
Time frame: 10 years post-operative
Subject Satisfaction as assessed by Forgotten Joint Score
Time frame: 10 years post-operative
Subject Satisfaction as assessed by Satisfaction Survey
Time frame: 10 years post-operative
Radiolucencies
Time frame: 10 years post-operative
To assess subject safety
Time frame: 10 years post-operative
To assess device tolerability within subject
Time frame: 10 years post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc..
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Component Survivorship (time frame: 10 years post-operative). 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 27 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.