Total Hip ArthroplastyNCT03164733
Age Dependency of Biological Reaction on Wear Particles
An observational study of Total Hip Arthroplasty and Wear, run by University of Jena.
Trial summary
Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (<60 years) have to expect at least one wear induced revision operation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Total Hip Arthroplasty, Wear
- What is being tested?
- incubation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Aug 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 patients having received a total hip arthroplasty 4 weeks before blood sample for this study
Who may be able to join
- having received a total hip arthroplasty 4 weeks before blood sample for this study
Who cannot join
- no informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.
The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.
- Conditions
- Total Hip Arthroplasty, Wear
- Being tested
- incubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incubationOther
standardized wear particles are co-incubated with isolated patient cells (monocytes)
| Study group | Role | What they receive |
|---|---|---|
| <40 | patients younger than 40 years Receives: Other: incubation | |
| 40-60 | patients younger than 60 years and not older than 40 years Receives: Other: incubation | |
| 60-80 | patients younger than 80 years and not older than 80 years Receives: Other: incubation | |
| >80 | patients older than 80 years Receives: Other: incubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
biological reaction
TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startAug 2017 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Matziolis, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164733
- Sponsor's protocol ID
- AgeWear
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Dependency of Biological Reaction on Wear Particles
- ClinicalTrials.gov ID
- NCT03164733
- Acronym / sponsor ID
- AgeWear
- Conditions
- Total Hip Arthroplasty, Wear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Aug 2017 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 24 May 2017 (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.
Wear is the main reason for revision operations after joint arthroplasty. While the survival of modern implants is often longer than the expected life span in old patients, young patients (<60 years) have to expect at least one wear induced revision operation. The reason is the throughout all registries consistantly significantly reduced implant survival rates in young patients. In the swedish arthrplasty registry the 15 year survival for patients older than 75 years is 95 % and for those younger than 50 years is 75 %. This corresponds to a 5fold increased revision rate (5 % vs. 25 %) 15 years after implantation. This significant difference cannot be explained by the higher activity of younger patients alone. Patient specific factors, that modulate the biological reaction on wear particles, are therefore highly probable. These could explain the significant age dependency of implant survival.
The main hypothesis of this study is therefore, that the biological reaction on wear particles depends on the patients age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| <40 | – | Other: incubationpatients younger than 40 years |
| 40-60 | – | Other: incubationpatients younger than 60 years and not older than 40 years |
| 60-80 | – | Other: incubationpatients younger than 80 years and not older than 80 years |
| >80 | – | Other: incubationpatients older than 80 years |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients having received a total hip arthroplasty 4 weeks before blood sample for this study
Key inclusion criteria (1 listed)
- having received a total hip arthroplasty 4 weeks before blood sample for this study
Key exclusion criteria (1 listed)
- no informed consent
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 |
|---|---|---|
| incubationstandardized wear particles are co-incubated with isolated patient cells (monocytes) | Other | 40-60, 60-80, <40, >80 |
Primary outcome
biological reaction
Time frame: one hour
TNF-alpha concentration one hour after incubation of patient cells with wear particles in-vitro
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty and Wear, run by University of Jena.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georg Matziolis, MD PhD (+49 36691 81011, g.matziolis@krankenhaus-eisenberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biological reaction (time frame: one hour). 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 24 May 2017.