Joint DiseasesNCT04147559
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc. at 2 sites in United States.
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?
- Total Hip Arthroplasty Implant
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2020to 1 Nov 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.
Who may be able to join
- 1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including 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 of their primary THA implantation.
Who cannot join
- Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
- 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
Show all 16Show fewer
- Has or had neuropathic joints
- Has or had hepatitis or HIV infection
- Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- Has 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
- Unwilling or unable to sign the Informed Consent document
- Has documented substance abuse issue
- 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 -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
HCA Research Institute, OrthoONE at Swedish Medical Center
Englewood, Colorado, 80113
HonorHealth Research Institute
Scottsdale, Arizona, 85258
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
- Total Hip Arthroplasty Implant
- Keywords
- Osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia
- Medical subject headings
- Joint Diseases, Osteoarthritis, Osteonecrosis, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip Arthroplasty ImplantDevice
Also called PROFEMUR® Preserve Classic Femoral Stem
Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.
What is being measured
The primary outcome is the main question the study is designed to answer.
Component Survivorship
The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.
Measured: 10 years post-operative
Secondary outcomes (7)
To determine the cumulative revision rate at specified intervals out to 10 years follow-up
Percentage of hips that were revised or replaced at each of the intervals for Year 1, Year 3, Year 5, Year 7 and Year 10 evaluation.
Measured: 10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.
The study will be reporting the final 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
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L
EQ-5D-5L 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
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
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.
The Satisfaction Survey consists of questions asked about how satisfied the patient is with the new implant.
Measured: 10 years post-operative
To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem
Radiolucencies are described around 7 zones and will be reporting the number of hips with radiolucencies present at a given zone.
Measured: 10 years post-operative
To characterize adverse events and adverse device effects
Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effects (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will also be provided.
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 posted1 Nov 2019
- Study start21 Oct 2020
- Primary completion1 May 2033 (estimated)
- Study completion1 Nov 2033 (estimated)
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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Assini, MD, Principal investigator, OrthoOne at Swedish Medical CenterJudd Cummings, MD, Principal investigator, HonorHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147559
- Sponsor's protocol ID
- 19H001
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2019
- Last updated
- 20 Mar 2024
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
- ClinicalTrials.gov ID
- NCT04147559
- Acronym / sponsor ID
- 19H001
- Conditions
- Joint Diseases
- Keywords
- Osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 May 2033 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 1 Nov 2019 (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
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.
Key inclusion criteria (5 listed)
- 1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including 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 of their primary THA implantation.
Key exclusion criteria (16 listed)
- Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
- 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
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 |
|---|---|---|
| Total Hip Arthroplasty ImplantAlso: PROFEMUR® Preserve Classic Femoral StemSingle study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads. | Device | – |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.
7 secondary outcomes
To determine the cumulative revision rate at specified intervals out to 10 years follow-up
Time frame: 10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.
Time frame: 10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L
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).
Time frame: 10 years post-operative
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.
Time frame: 10 years post-operative
To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem
Time frame: 10 years post-operative
To characterize adverse events and adverse device effects
Time frame: 10 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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.
Joseph Assini, MD principal investigator
OrthoOne at Swedish Medical Center
Judd Cummings, MD principal investigator
HonorHealth Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Diseases, run by MicroPort Orthopedics Inc. at 2 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 5 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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 20 Mar 2024.