Joint DiseaseNCT04064008
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in Poland.
Trial summary
Single center, prospective follow-up of previously implanted subjects Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Joint Disease
- What is being tested?
- PROFEMUR® Z Revision Femoral Stem
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 4 Apr 2019to Apr 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem
Who may be able to join
- Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
- Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
- Subject is willing and able to complete required study visits or assessments.
- Plans to be available through the 10 year postoperative follow-up visit.
- Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
- the PROFEMUR Z Revision Femoral Stem was implanted in both,
Show all 9Show fewer
- all other aspects of the Inclusion/Exclusion Criteria are satisfied,
- enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
- 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 currently enrolled in another clinical study which could affect the endpoints of this protocol.
- Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
- Has or had an overt infection at the time of implantation.
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
- Has or had 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.
Show all 10Show fewer
- Subjects unwilling to sign the Informed Consent document.
- Subjects with substance abuse issues.
- Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Subjects who are incarcerated or have pending incarceration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Single center, prospective follow-up of previously implanted subjects
Read the detailed description
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
- Conditions
- Joint Disease
- Being tested
- PROFEMUR® Z Revision Femoral Stem
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFEMUR® Z Revision Femoral StemDevice
Total Hip Total Hip Arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Primary Total Hip Arthroplasty | Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem Receives: Device: PROFEMUR® Z Revision Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of ProFemur Z Stem out to 10 years
Kaplan-Meier survivorship at specific intervals out to 10 years follow up
Measured: 10 years.
Secondary outcomes (2)
Revision rate of the Profemur Z stem out to 10 years
Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up.
Measured: 2-5 years, 5-7 years, and 10 years.
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores
The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'.
Measured: 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 posted21 Aug 2019
- Study start4 Apr 2019
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064008
- Sponsor's protocol ID
- 12-LJH-002M
- Status last verified
- Nov 2023
- First submitted
- 18 May 2019
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
- ClinicalTrials.gov ID
- NCT04064008
- Acronym / sponsor ID
- 12-LJH-002M
- Conditions
- Joint Disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 21 Aug 2019 (actual)
- 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.
Single center, prospective follow-up of previously implanted subjects
Detailed description
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Total Hip Arthroplasty | – | Device: PROFEMUR® Z Revision Femoral StemSingle study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem
Key inclusion criteria (9 listed)
- Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
- Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
- Subject is willing and able to complete required study visits or assessments.
- Plans to be available through the 10 year postoperative follow-up visit.
- Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
Key exclusion criteria (10 listed)
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
- Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
- Has or had an overt infection at the time of implantation.
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
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® Z Revision Femoral StemTotal Hip Total Hip Arthroscopy | Device | Primary Total Hip Arthroplasty |
Primary outcome
Survivorship of ProFemur Z Stem out to 10 years
Time frame: 10 years.
Kaplan-Meier survivorship at specific intervals out to 10 years follow up
2 secondary outcomes
Revision rate of the Profemur Z stem out to 10 years
Time frame: 2-5 years, 5-7 years, and 10 years.
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores
Time frame: 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 14 Nov 2023.
Related trials for Joint Disease
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Recruiting
Oral Nutritional Optimization in Total Joint Arthroplasty
Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
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.
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 Poland.
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 9 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 14 Nov 2023. 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 Poland. 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?
Survivorship of ProFemur Z Stem out to 10 years (time frame: 10 years.). 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 14 Nov 2023.