Joint DiseaseNCT02397746
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems
An observational study of Joint Disease, run by MicroPort Orthopedics Inc..
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) 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?
- total hip arthroplasty implant
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 20 Dec 2021
- 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 PROFEMUR® Gladiator femoral stems
Who may be able to join
- 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 implanted with a metal-on-metal articulation
- Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
- Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- 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 have pending incarceration
About this study
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) European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.
Read the detailed description
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
- Conditions
- Joint Disease
- Being tested
- total hip arthroplasty implant
- Keywords
- osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, 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.
total hip arthroplasty implantDevice
Also called PROFEMUR Gladiator femoral stem
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty | Single group previously implanted with the following combination of components: PROFEMUR® Gladiator femoral stem, MicroPort acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head. Receives: Device: total hip arthroplasty implant |
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 of all components at specified intervals out to 10 years follow-up.
Measured: 10 years post-operative
Secondary outcomes (1)
Patient functional outcomes
To characterize total functional scores, as assessed by Oxford Hip Scores and 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 posted25 Mar 2015 (estimated)
- Study startJul 2015
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Why it stopped: Research site unable to support further study requirements
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.
- 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
- 75 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
- NCT02397746
- Sponsor's protocol ID
- 12-LJH-002J
- Status last verified
- Dec 2022
- First submitted
- 19 Mar 2015
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 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® Gladiator Cemented Femoral Stems
- ClinicalTrials.gov ID
- NCT02397746
- Acronym / sponsor ID
- 12-LJH-002J
- Conditions
- Joint Disease
- Keywords
- osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, rheumatoid arthritis, correction of functional deformity, revision procedures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Research site unable to support further study requirements
- Enrolment
- 75 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 25 Mar 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) European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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.
Detailed description
Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty | – | Device: total hip arthroplasty implantSingle group previously implanted with the following combination of components: PROFEMUR® Gladiator femoral stem, MicroPort acetabular shell, MicroPort Orthopedics polyethylene or ceramic liner, MicroPort Orthopedics metal or ceramic femoral head. |
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® Gladiator femoral stems
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Subjects implanted with a metal-on-metal articulation
- Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
- Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subjects unwilling to sign the Informed Consent document
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 Gladiator femoral stem | Device | Total Hip Arthroplasty |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.
1 secondary outcome
Patient functional outcomes
Time frame: Screening (First Available), 2-5 years, 5-7 years, and 10 years
Results and safety
The study was stopped early (reason given: Research site unable to support further study requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
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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 Disease, 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Dec 2022. 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 stopped early (reason given: Research site unable to support further study requirements). Results are not available in the source record.
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 Dec 2022.