Joint DiseaseNCT02507258
PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in France.
Trial summary
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Joint Disease
- What is being tested?
- PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2017to Dec 2028
- 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: Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component
Who may be able to join
- Subject has undergone primary THA for any of the following:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; or
- Correction of functional deformity
- Subject is implanted with the specified combination of components
- Subject is willing and able to complete required study visits or assessments
Who cannot join
- Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subjects unwilling to sign the Informed Consent document
- Subjects with substance abuse issues
- Subjects who are incarcerated or having pending incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
- Conditions
- Joint Disease
- Being tested
- PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell
- Keywords
- osteoarthritis, avascular necrosis, correction of functional deformity, painful hip dysplasia, protrusio acetabuli, rheumatoid arthritis, ankylosis
- Medical subject headings
- Joint Diseases, Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFEMUR® Am Femoral Stem w/ PROCOTYL® O ShellDevice
PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component
| Study group | Role | What they receive |
|---|---|---|
| PROFEMUR® Am Femoral Stem | Single study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component Receives: Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell |
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 survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.
Measured: 10 years post-operative
Secondary outcomes (1)
Patient functional outcomes (hip specific)
To characterize total functional scores, as assessed by Oxford Hip and EQ-5D-3L scores
Measured: Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startDec 2017 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Sponsor decision to not renew CE mark on product. Therefore study not needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gérard Giordano, MD, Principal investigator, Hopital Joseph Ducuing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507258
- Sponsor's protocol ID
- 12-LJH-002K
- Status last verified
- Jun 2018
- First submitted
- 21 Jul 2015
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
- ClinicalTrials.gov ID
- NCT02507258
- Acronym / sponsor ID
- 12-LJH-002K
- Conditions
- Joint Disease
- Keywords
- osteoarthritis, avascular necrosis, correction of functional deformity, painful hip dysplasia, protrusio acetabuli, rheumatoid arthritis, ankylosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to not renew CE mark on product. Therefore study not needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jul 2015 (estimated)
- 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.
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROFEMUR® Am Femoral Stem | – | Device: PROFEMUR® Am Femoral Stem w/ PROCOTYL® O ShellSingle study group previously implanted with a primary PROFEMUR® Am Femoral Stem and PROCOTYL® O HA Coated Acetabular Component |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component
Key inclusion criteria (6 listed)
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis; or
- Correction of functional deformity
- Subject is implanted with the specified combination of components
- Subject is willing and able to complete required study visits or assessments
Key exclusion criteria (6 listed)
- Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subjects unwilling to sign the Informed Consent document
- Subjects with substance abuse issues
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® Am Femoral Stem w/ PROCOTYL® O ShellPROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component | Device | PROFEMUR® Am Femoral Stem |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. Measured by capturing date of revision or removal of the device.
1 secondary outcome
Patient functional outcomes (hip specific)
Time frame: Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval
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 7 Jun 2018.
- 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.
Gérard Giordano, MD principal investigator
Hopital Joseph Ducuing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in France.
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 6 inclusion and 6 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 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 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 7 Jun 2018.