Joint DiseaseNCT02314611
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator HA Coated Modular Femoral Stems
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Belgium.
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® Gladiator HA Coated Modular Femoral Stem
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Nov 2023
- 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® Gladiator HA Coated Modular Femoral Stem
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
- Previously implanted bilateral subjects can have both THAs enrolled in the study provided: 1) the specified combination of components were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Investigator Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Medisch Centrum Latem (outpatient clinic associated with AZ Maria-Middelares)
Sint-Martens-Latem, Flanders, 9830
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) 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® Gladiator HA Coated Modular 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® Gladiator HA Coated Modular Femoral StemDevice
Also called Primary hip replacement device
Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem
| Study group | Role | What they receive |
|---|---|---|
| PROFEMUR® Gladiator HA Coated Stem | Single study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite) Receives: Device: PROFEMUR® Gladiator HA Coated Modular Femoral Stem |
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 (2)
Patient functional outcomes (hip specific)
To characterize total functional scores, as assessed by Hip disability and Osteoarthritis Outcome Scores (HOOS)
Measured: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval
Patient functional outcomes (quality of life)
To characterize total functional scores, as assessed by EQ-5D-3L scores
Measured: 5 months, 1, 2, 5, 7, and 10 years 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 posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2019
- Study completionNov 2023
Why it stopped: The primary reason for this study was to collect safety and performance data to meet regulatory requirements. However, these requirements have changed over time. Our recentassessment has determined that now there is sufficient data on this product.
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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Van Overschelde, MD, Principal investigator, Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314611
- Sponsor's protocol ID
- 12-LJH-002D
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2014
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. 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 HA Coated Modular Femoral Stems
- ClinicalTrials.gov ID
- NCT02314611
- Acronym / sponsor ID
- 12-LJH-002D
- 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
- TerminatedReason stopped: The primary reason for this study was to collect safety and performance data to meet regulatory requirements. However, these requirements have changed over time. Our recentassessment has determined that now there is sufficient data on this product.
- Enrolment
- 154 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2023 (actual)
- 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 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® Gladiator HA Coated Stem | – | Device: PROFEMUR® Gladiator HA Coated Modular Femoral StemSingle study group previously implanted with a primary PROFEMUR® Gladiator HA Coated Modular Femoral Stem (HA = Hydroxyapatite) |
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® Gladiator HA Coated Modular Femoral Stem
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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® Gladiator HA Coated Modular Femoral StemAlso: Primary hip replacement deviceTotal Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem | Device | PROFEMUR® Gladiator HA Coated Stem |
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.
2 secondary outcomes
Patient functional outcomes (hip specific)
Time frame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval
Patient functional outcomes (quality of life)
Time frame: 5 months, 1, 2, 5, 7, and 10 years beginning with first available follow-up interval
Results and safety
The study was stopped early (reason given: The primary reason for this study was to collect safety and performance data to meet regulatory requirements. However, these requirements have changed over time. Our recentassessment has determined that now there is sufficient data on this product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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. This study is not recruiting at the moment.
Philippe Van Overschelde, MD principal investigator
Algemeen Ziekenhuis Maria-Middelares (Gent, Belgium)
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 Belgium.
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 5 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 9 Jan 2024. 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 Belgium. 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 stopped early (reason given: The primary reason for this study was to collect safety and performance data to meet regulatory requirements. However, these requirements have changed over time. Our recentassessment has determined that now there is sufficient data on this product.). 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 9 Jan 2024.