Joint DiseaseNCT02309593
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems
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) 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® Xm Femoral Stems
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to 21 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: Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.
Who may be able to join
- Subject previously underwent / is a candidate for 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 has been previously implanted / is a candidate to be implanted with the specified combination of components
- Subject is willing and able to complete required study visits or assessments
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- Not previously implanted subject is able to undergo primary THA procedure
- 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
- Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:
- it occurs not more than two years after the index THA
- the specified combination of components is used
- 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
- Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
- Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subject is unwilling to sign the Informed Consent document
- Subject has substance abuse issues
- Subject is incarcerated or has pending incarceration
- Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip
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- In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:
- Subject has any of the following contraindications at the time of implantation
- Overt infection
- Distant foci of infections (which may cause hematogenous spread to the implant site)
- Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram
- Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
- Neuropathic joints
- Hepatitis or HIV infection
- Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
Trial locations and contacts
1 site in 1 country.
Germany1 site
St. Marien-Hospital Mülheim, Klinik für Orthopädie, Unfall & Wiederherstellungschirurgie
Mülheim, 45468
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® Xm Femoral Stems
- 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® Xm Femoral StemsDevice
Also called Primary hip replacement device
THA using PROFEMUR® Xm Femoral Stems
| Study group | Role | What they receive |
|---|---|---|
| PROFEMUR® Xm Femoral Stems | Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells. Receives: Device: PROFEMUR® Xm 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 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: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Patient functional outcomes (quality of life)
To characterize total functional scores, as assessed by EQ-5D-3L scores
Measured: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Why it stopped: PI change, hospital change and covid -19 caused lost-to-follow up of most of the subjects
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Jäger, MD, Principal investigator, St. Marien-Hospital Mülheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309593
- Sponsor's protocol ID
- 12-LJH-002A
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2014
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 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® Xm Femoral Stems
- ClinicalTrials.gov ID
- NCT02309593
- Acronym / sponsor ID
- 12-LJH-002A
- 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: PI change, hospital change and covid -19 caused lost-to-follow up of most of the subjects
- Enrolment
- 52 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 5 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® Xm Femoral Stems | – | Device: PROFEMUR® Xm Femoral StemsSingle study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.
Key inclusion criteria (18 listed)
- Subject previously underwent / is a candidate for 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 has been previously implanted / is a candidate to be implanted with the specified combination of components
Key exclusion criteria (15 listed)
- Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
- Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
- Subject is unwilling to sign the Informed Consent document
- Subject has substance abuse issues
- Subject is incarcerated or has 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® Xm Femoral StemsAlso: Primary hip replacement deviceTHA using PROFEMUR® Xm Femoral Stems | Device | PROFEMUR® Xm Femoral Stems |
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: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Patient functional outcomes (quality of life)
Time frame: Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Results and safety
The study was stopped early (reason given: PI change, hospital change and covid -19 caused lost-to-follow up of most of the subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 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.
Marcus Jäger, MD principal investigator
St. Marien-Hospital Mülheim
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 18 inclusion and 15 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 28 Apr 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?
The study was stopped early (reason given: PI change, hospital change and covid -19 caused lost-to-follow up of most of the subjects). 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 28 Apr 2022.