Joint DiseaseNCT02823834
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Germany.
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) 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 Plasma Femoral Stems
- Type of treatment
- Medical device
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jun 2017to Jun 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 a PROFEMUR® Gladiator Plasma Femoral Stem and PROCOTYL® L Beaded Acetabular Component
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
Show all 11Show fewer
- Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
- the specified combination of components were implanted in both
- all other aspects of the Inclusion/Exclusion Criteria are satisfied
- enrollment does not exceed the subject count specified in the Clinical Trial Agreement
- the subject agrees to a second Informed Consent document specific to the second THA.
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) at the time of their primary THA 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 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® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded 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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 Plasma Femoral Stems
- Keywords
- osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia, rheumatoid arthritis, correction of functional deformity
- 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 Plasma Femoral StemsDevice
Also called Primary hip replacement device
THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components
| Study group | Role | What they receive |
|---|---|---|
| PROFEMUR® Gladiator Plasma Femoral Stems | Single study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads. Receives: Device: PROFEMUR® Gladiator Plasma Femoral Stems |
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 analysis 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 Oxford Hip Scores
Measured: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
Patient functional outcomes (quality of life)
To characterize total functional scores, as assessed by EQ-5D-3L scores
Measured: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start16 Jun 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 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.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Pimienta, Principal investigator, Elbe Kliniken Buxtehude
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823834
- Sponsor's protocol ID
- 12-LJH-002H
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2016
- Last updated
- 8 Jul 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 8 Jul 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 Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
- ClinicalTrials.gov ID
- NCT02823834
- Acronym / sponsor ID
- 12-LJH-002H
- Conditions
- Joint Disease
- Keywords
- osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia, rheumatoid arthritis, correction of functional deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jul 2016 (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) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 Plasma Femoral Stems | – | Device: PROFEMUR® Gladiator Plasma Femoral StemsSingle study group either previously implanted with the following combination of components: PROFEMUR® Gladiator Plasma Femoral Stems, PROCOTYL® L Beaded Acetabular Shells, Polyethylene or Ceramic Liners, and Metal or Ceramic Femoral Heads. |
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 Plasma Femoral Stem and PROCOTYL® L Beaded Acetabular Component
Key inclusion criteria (11 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) at the time of their primary THA 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 |
|---|---|---|
| PROFEMUR® Gladiator Plasma Femoral StemsAlso: Primary hip replacement deviceTHA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components | Device | PROFEMUR® Gladiator Plasma Femoral Stems |
Primary outcome
Component Survivorship
Time frame: 10 years post-operative
The primary objective of this study is to estimate survivorship analysis of all components at specified intervals out to 10 years follow-up.
2 secondary outcomes
Patient functional outcomes (hip specific)
Time frame: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
Patient functional outcomes (quality of life)
Time frame: 2-5 years, 5-7 years and 10 years postoperatively beginning with first available visit
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 8 Jul 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.
Jose Pimienta principal investigator
Elbe Kliniken Buxtehude
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 Germany.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 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 Germany. 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 8 Jul 2022.