Arthroplasty, Replacement, HipNCT04542174
PMCF 8 Year Results TRJ®
An observational study of Arthroplasty, Replacement, Hip and Follow-Up Study, run by Aesculap AG at 1 site in Germany.
Trial summary
The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Follow-Up Study
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2020to 26 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
- patients have received a TRJ® prosthesis in 2012
- Patient did participate in the 2 years results evaluation 2014
- Patient gave his written consent for study participation
Who cannot join
- patient is pregnant
- patient < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results
The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results
- Conditions
- Arthroplasty, Replacement, Hip, Follow-Up Study
- Keywords
- Trochanter retaining joint replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate of the stem
The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.
Measured: at follow-up examination approximately 8 years after primary intervention
Secondary outcomes (11)
Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
The Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) is a 40 items patient reported outcome score (PROM) designed specifically to evaluate the physical functionality of hip osteoarthritis patients. The HOOS offers 5 subgroups, each with 100 points as best result.
Measured: at follow-up examination approximately 8 years after primary intervention
Harris Hip Score (HHS)
The Harris Hip Score (HHS) is one of the most used scores in total hip arthroplasty, mainly combining range of motion questions with questions regarding daily life activities.
Measured: at follow-up examination approximately 8 years after primary intervention
Rate of Adverse and Serious Adverse Events
All Adverse Events (AE) / Serious Adverse Events (SAE) either observed during the follow-up examination, found in the patient file of the hospital or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TRJ® Total Hip Arthroplasty procedure in 2012 are of interest.
Measured: at follow-up examination approximately 8 years after primary intervention
Pain Assessment
Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line.
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Inlay wear
Inlay wear is assessed on AP x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements.
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bony Osseointegration or conspicuous features of the cup
Bony Osseointegration or conspicuous features of the Cup are assessed on anterior-posterior x-rays of the cup and will be analysed according to the zones defined by DeLee and Charnley. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements.
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Migration of the stem in mm
Migration of the stem is assessed in [mm] relative to discharge x-rays
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the medial stem neck
Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the Trochanter Major
Bone Resorption is assessed on anterior-posterior and lateral x-rays of the stem
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
Bony Osseointegration or conspicuous features of the stem are assessed on anterior-posterior and lateral x-rays of the stem and will be analysed according to the zones defined by Gruen. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements
Measured: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Heterotopic Ossification
Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray
Measured: at follow-up examination approximately 8 years after primary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start10 Sep 2020
- Primary completion26 Sep 2021
- Study completion26 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 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
- NCT04542174
- Sponsor's protocol ID
- AAG-O-H-1908
- Status last verified
- Jan 2022
- First submitted
- 2 Sep 2020
- Last updated
- 14 Jan 2022
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results
- ClinicalTrials.gov ID
- NCT04542174
- Acronym / sponsor ID
- AAG-O-H-1908
- Conditions
- Arthroplasty, Replacement, Hip, Follow-Up Study
- Keywords
- Trochanter retaining joint replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 26 Sep 2021 (actual)
- First posted
- 9 Sep 2020 (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.
The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (3 listed)
- patients have received a TRJ® prosthesis in 2012
- Patient did participate in the 2 years results evaluation 2014
- Patient gave his written consent for study participation
Key exclusion criteria (2 listed)
- patient is pregnant
- patient < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate of the stem
Time frame: at follow-up examination approximately 8 years after primary intervention
The survival of the TRJ® stem prosthesis will be analyzed using the "Kaplan-Meier". Isolated revisions of the inlay and / or of the acetabular components (with the stem being kept in place) are documented, but assessed separately.
11 secondary outcomes
Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Time frame: at follow-up examination approximately 8 years after primary intervention
Harris Hip Score (HHS)
Time frame: at follow-up examination approximately 8 years after primary intervention
Rate of Adverse and Serious Adverse Events
Time frame: at follow-up examination approximately 8 years after primary intervention
Pain Assessment
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Inlay wear
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bony Osseointegration or conspicuous features of the cup
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Migration of the stem in mm
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the medial stem neck
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Bone resorption at the Trochanter Major
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
Time frame: at follow-up examination approximately 8 years after primary intervention
Radiological Outcome: Heterotopic Ossification
Time frame: at follow-up examination approximately 8 years after primary intervention
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 14 Jan 2022.
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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 Arthroplasty, Replacement, Hip and Follow-Up Study, 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 3 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 14 Jan 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 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?
Survival rate of the stem (time frame: at follow-up examination approximately 8 years after primary intervention). 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 Jan 2022.