Total Hip ArthroplastyNCT02019862
TRJ Post Market Clinical Follow Up
An observational study of Total Hip Arthroplasty, run by Aesculap AG at 1 site in Germany.
Trial summary
Clinical and radiological 2 years results of TRJ® Hip Stem. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- TRJ® Total Hip Arthroplasty
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Feb 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: specialist clinical centre
Who may be able to join
- TRJ® implantation performed
- patient consent available for participation in the study
Who cannot join
- permanent cortisone therapy
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRJ PMCF Köln: 2-years Results
Clinical and radiological 2 years results of TRJ® Hip Stem.
- Conditions
- Total Hip Arthroplasty
- Being tested
- TRJ® Total Hip Arthroplasty
- Keywords
- Total hip arthroplasty, TRJ, PMCF, Hip stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRJ® Total Hip ArthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| TRJ® | Not described Receives: Device: TRJ® Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival
Measured: 24 months
Secondary outcomes (5)
Clinical Outcome
Harris Hip Score
Measured: 24 months
Osteolysis
Radiological Outcome
Measured: 24 months
Ossification
Radiological Outcome
Measured: 24 months
Migration
Radiological Outcome
Measured: 24 months
TRJ® Implant Position
Radiological Outcome
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019862
- Sponsor's protocol ID
- AAG-O-H-1314
- Status last verified
- Apr 2015
- First submitted
- 4 Dec 2013
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRJ PMCF Köln: 2-years Results
- ClinicalTrials.gov ID
- NCT02019862
- Acronym / sponsor ID
- AAG-O-H-1314
- Conditions
- Total Hip Arthroplasty
- Keywords
- Total hip arthroplasty, TRJ, PMCF, Hip stem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2013 (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.
Clinical and radiological 2 years results of TRJ® Hip Stem.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRJ® | – | Device: TRJ® Total Hip Arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- specialist clinical centre
Key inclusion criteria (2 listed)
- TRJ® implantation performed
- patient consent available for participation in the study
Key exclusion criteria (2 listed)
- permanent cortisone therapy
- alcohol or drug abuse
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 |
|---|---|---|
| TRJ® Total Hip Arthroplasty | Device | TRJ® |
Primary outcome
Implant Survival
Time frame: 24 months
5 secondary outcomes
Clinical Outcome
Time frame: 24 months
Osteolysis
Time frame: 24 months
Ossification
Time frame: 24 months
Migration
Time frame: 24 months
TRJ® Implant Position
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
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 Total Hip Arthroplasty, run by Aesculap AG 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implant Survival (time frame: 24 months). 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 16 Apr 2015.