Joint DiseaseNCT02314702
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in United Kingdom.
Trial summary
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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… 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® L Revision Femoral Stem
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2015to Oct 2027
- 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: Patients who have been previously implanted with PROFEMUR® L Revision Femoral Components
Who may be able to join
- Has undergone revision total hip arthroplasty
- 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 currently enrolled in another clinical study
- Subjects unwilling to sign the Informed Consent document
- Subjects with substance abuse issues
- Subjects who are incarcerated or have pending incarceration
Trial locations and contacts
1 site in 1 country.
About this study
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.
- Conditions
- Joint Disease
- Being tested
- PROFEMUR® L Revision Femoral Stem
- Keywords
- Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity, Revision procedures
- Medical subject headings
- Joint Diseases, Osteoarthritis, Osteonecrosis, Ankylosis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFEMUR® L Revision Femoral StemDevice
Also called Hip Revision Device
Revision Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Revision Total Hip Arthroplasty | Single study group previously implanted with a PROFEMUR® L Revision Femoral Stem Receives: Device: PROFEMUR® L Revision Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who require a revision
The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
Measured: 10 years post-operative
Secondary outcomes (2)
Patient functional score on the the Oxford Hip Score instrument
To characterize patient hip-related health status, as assessed by Oxford Hip Scores
Measured: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Patient functional score on the EQ-5D-3L instrument
To characterize patient general health status, as assessed by EQ-5D-3L scores
Measured: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study start4 Sep 2015
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
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
- 26 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
- NCT02314702
- Sponsor's protocol ID
- 12-LJH-002L
- Status last verified
- Oct 2022
- First submitted
- 3 Dec 2014
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
- ClinicalTrials.gov ID
- NCT02314702
- Acronym / sponsor ID
- 12-LJH-002L
- Conditions
- Joint Disease
- Keywords
- Osteoarthritis, Avascular necrosis, Ankylosis, Protrusio acetabuli, Painful hip dysplasia, Rheumatoid arthritis, Correction of functional deformity, Revision procedures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2015 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Dec 2014 (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 PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the 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 MEDDEV 2.12/2 rev 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision Total Hip Arthroplasty | – | Device: PROFEMUR® L Revision Femoral StemSingle study group previously implanted with a PROFEMUR® L Revision Femoral Stem |
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 PROFEMUR® L Revision Femoral Components
Key inclusion criteria (3 listed)
- Has undergone revision total hip arthroplasty
- Subject is implanted with the specified combination of components
- Subject is willing and able to complete required study visits or assessments
Key exclusion criteria (4 listed)
- Subjects currently enrolled in another clinical study
- Subjects unwilling to sign the Informed Consent document
- Subjects with substance abuse issues
- Subjects who are incarcerated or have pending incarceration
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® L Revision Femoral StemAlso: Hip Revision DeviceRevision Total Hip Arthroplasty | Device | Revision Total Hip Arthroplasty |
Primary outcome
Number of participants who require a revision
Time frame: 10 years post-operative
The primary objective of this study is to estimate the revision rate of all components at specified intervals out to 10 years follow-up.
2 secondary outcomes
Patient functional score on the the Oxford Hip Score instrument
Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Patient functional score on the EQ-5D-3L instrument
Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
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 13 Oct 2022.
- 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.
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 United Kingdom.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2022. 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 United Kingdom. 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?
Number of participants who require a revision (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 13 Oct 2022.